SC

Exclusive: Nikki Haley’s Nephron Pharmaceutical Problem Deepens

WHISTLEBLOWERS: COMPANY’S SOUTH CAROLINA LAUNCH HAS BEEN “ONE EPIC DISASTER AFTER ANOTHER” By FITSNEWS  ||  A few weeks back this website published an update on Nephron Pharmaceuticals – the company S.C. Gov. Nikki Haley welcomed to South Carolina three years ago to great fanfare. “It’s another great day in South Carolina,”…

WHISTLEBLOWERS: COMPANY’S SOUTH CAROLINA LAUNCH HAS BEEN “ONE EPIC DISASTER AFTER ANOTHER”

By FITSNEWS  ||  A few weeks back this website published an update on Nephron Pharmaceuticals – the company S.C. Gov. Nikki Haley welcomed to South Carolina three years ago to great fanfare.

“It’s another great day in South Carolina,” Haley said at the time. “We celebrate Nephron Pharmaceuticals’ decision to locate its new manufacturing facility in the Midlands and create hundreds of well-paying new jobs. This is a big win for our state.”

S.C. Commerce Secretary Bobby Hitt joined in the cheerleading, noting that Nephron would “have a huge positive impact on our state.”

How many jobs?  Haley and Hitt touted an estimated 707 new positions – at more than $70,000 a pop.

Three years later, though, these promises have yet to materialize – despite the company receiving a direct appropriation of $4.5 million from the S.C. Department of Commerce to build its new facility (on top of millions more in government-subsidized training grants, tax credits and property tax breaks).  In fact according to former and current Nephron whistleblowers, things appear to be moving in reverse.

FITS was suspicious of this deal from the beginning – and we said so.  In fact, we published a detailed story regarding its questionable financials – and also wrote extensively about pay-to-play allegations involving Nephron and the governor.

NIKKI HALEY
NIKKI HALEY

We also busted Haley in a lie regarding her prior connections to the company’s founders – Bill Kennedy and his wife, Lou Kennedy (who have contributed thousands of dollars to Haley’s political campaigns and who frequently allowed Haley access to Nephron’s private jet).

After the mainstream media picked up on our story about Haley’s lie, her spokesman claimed she “misspoke” about her relationship with the Kennedys – curtly correcting the record about when she met them (and under what circumstances).

And as is the custom in Haley’s administration, the lie was drowned out by spin.

“The governor’s job is to build relationships that benefit the people of South Carolina,” her spokesman Rob Godfrey said. “And there is no better example of her doing that than today’s announcement of more than 700 jobs and millions of dollars in investment in our state.”

Yeah?

About those “benefits …”

***

“DROPPING LIKE FLIES”

In our mid-August report, we noted that Nephron employed only “100 full-time South Carolina” workers – and that the company was relying increasingly on imported workers from its Orlando, Florida headquarters.

“The SC folks are dropping like flies,” we were told at the time.

Our report also noted that in addition to problems with the quality of the Palmetto State’s workforce, Nephron was “facing a host of problems including major financial troubles, high turnover among its senior executives, legal drama associated with several recent terminations (and) issues with the U.S. Food and Drug Administration (FDA), delays in production.”

We also reported that Nephron had retained The Huron Group, a Chicago-based company that helps its clients “improve performance, comply with complex regulations and reduce costs—delivering measurable, sustainable results.”

What’s happened since we published our report?  Brace yourself … because you’re about to see the “loser” side of “picking winners and losers” in the economy with taxpayer money.

***

CASH CRUNCH CONFIRMED

First of all, FITS previous reporting on Nephron’s financial troubles have been confirmed.  Shortly after our story ran, Nephron confirmed it had retained the The Huron Group – which issued a press release stating its goal was to help the company “reposition its operating and financial story to lenders.”

Nice …

Three weeks after our story ran, the company announced it had completed a $280 million refinancing plan.  Despite its financial issues, the company reaffirmed to a local business journal its intention to invest $313 million in South Carolina and employ more than 700 workers within ten years at an average wage of $71,000.

LOU KENNEDY
LOU KENNEDY

Months earlier, similar claims were made in the fawning coverage Nephron received from The (Columbia, S.C.) State newspaper on the occasion of the grand opening of its gleaming Cayce, S.C. facility – which Haley referred to as the “Taj Mahal.”

Specifically, Nephron vowed it would “approach sterile drug production” by the end of 2014.  Its executives also said they would “blow through” previously announced job totals.

That’s consistent with other recent promises made by Nephron CEO Lou Kennedy, who in early 2013 told veteran establishment reporter James T. Hammond that Nephron was going to exceed its original job totals – and achieve its “much higher” employment numbers in less time than originally projected.

***

WHISTLEBLOWERS SPEAK

In an effort to gain a better sense of Nephron’s progress in making good on these various promises, FITS spoke with several current and former employees of the company recently.  Needless to say, these whistleblowers told us – to a person – a vastly different story than the one being told by South Carolina’s politicians, corporate cronies and their apologists in the legacy media.

Where to start?

First, let’s look at the number of employees currently working inside the facility.  According to our sources, Nephron’s workforce has declined from 125 employees to roughly 60-70 employees over the last few months.  In other words three years after vowing to bring 700 jobs to South Carolina, Nephron is only ten percent of the way there – and moving in the wrong direction.

“They are making up reasons for letting people go,” one of our whistleblowers said.

Not only that, of the employees currently working at the facility our sources say only 25-30 are from South Carolina – and even worse the company’s Palmetto State human resources department has been “shut down.”

Doesn’t bode well for future hiring, does it?

Nope.  Also, the few employees who are left working inside Haley’s “Taj Mahal” are reportedly only making an average of $45,000 a year – well below the $71,000 figure Nephron has frequently cited.

***

“WORST START UP I HAVE EVER SEEN”

Beyond the shrinking job totals and lower-than-expected salaries, Nephron’s South Carolina facility is also a year behind schedule when it comes to actually manufacturing medicine – a process that’s been marred by ongoing incompetence and, in one case, allegations of corporate espionage.

“They are not producing medicine for sale as of October 1,” one whistleblower told us.  “It’s been one epic disaster after another.”

Another whistleblower flatly told us the U.S. Food and Drug Administration (FDA) “is not going to approve them to run product this year.”

In fact as of this writing, Nephron’s South Carolina plant has yet to successfully complete its trial batches – or “PV” (product validation) runs – due to a myriad of problems.  At least three such “PV” runs – required by the FDA – have reportedly “failed,” according to our sources.

Among the issues?  Shoddy ventilation and electrical work – which is obviously a serious issue in a manufacturing facility that’s regulated for public health.   According to our sources, Nephron’s vent system was built too low for several of its larger machines – and untrained employees spent three weeks “raising the vents.”

Not only was this delay extremely costly, the new ventilation system apparently wasn’t professionally installed – with one employee telling us “they used whatever employees were on the site” to complete the job.  Similarly, Nephron reportedly fired its electrical installation team during the middle of its work – and had existing employees finish the wiring of the new facility.

“I’ve worked with several start-ups,” one whistleblower told us.  “This has been by far the worst start-up I have ever seen.  They hired a hotel manager to run the project – a guy with no idea what he was doing.  No one there had start-up experience.”

“They don’t have anybody there who knows what they area doing,” another added.  “And no one’s getting training.”

***

“CEASE AND DESIST”

By far the most damaging allegation leveled against Nephron’s South Carolina facility is that it engaged in corporate espionage – allegedly stealing proprietary pharmaceutical “batch records” prepared by another company, The Ritedose Corporation (TRC) of Columbia, S.C.

“Nephron has stolen information from another company,” one of our whistleblowers said, highlighting documents obtained from Nephron that still bear the TRC name and TRC-specific terminology.

Another one of our sources confirmed the theft – telling us the company hired a former TRC employee who “had all the documents on his computer.”

According to both sources, Nephron attempted to conceal this alleged espionage by repackaging the documents – although “like everything else they did they botched it.”  As a result, the documents still contained identifiable information tying the batch records back to TRC.

According to one of our sources Nephron received a “cease and desist” letter from TRC which – in the words of an employee who saw it – “basically said we know you have our info and are using it and you are not allowed to do so.”

Months after the letter was received, though, Nephron was reportedly still using the proprietary information it allegedly stole.

A copy of the cease and desist letter was reportedly sent to the FDA, although neither the agency nor TRC immediately returned our calls to discuss the alleged corporate espionage.

***

“THEY CAN’T WORK THE MACHINES”

SIGPAK TTP
A BOSCH SIGPAK TTP

According to our sources, Nephron’s biggest problem in getting its South Carolina facility up and running is the fundamental inability of its work force to handle the complex machinery and work processes required to make medicine.  And the lack of resources available to train them.

“People there aren’t getting the training they need – a lot of them have never seen an FDA-regulated environment before,” one whistleblower told us. “Manufacturing and sterilization processes are all screwed up.”

For example recently sterilized areas are often immediately re-contaminated with non-sterile cleaning equipment due to the fact “the employees don’t know any better and no one is showing them how to do it properly.”

As for the manufacturing process itself, we’re told there are major problems related to the operation of a pair of new $12 million Sigpak TTP packaging machines recently purchased from Bosch.  These problems reportedly began when Nephron had to delay receipt of the machines due to its cash flow problems.

“Four of them were ordered but they could only pay for two of them and only one of them is up and running,” one source told us.  “Neither of the newer Sigpak models are currently up and running.”

Complicating matters, training on the new machines was reportedly cancelled due to cost considerations – a decision our whistleblowers say Bosch advised against in the most strenuous of terms.

“They told Nephron it was stupid,” one told us.

Nephron is said to be bringing in employees from Florida in an effort to get the machines up and running, but according to our sources as of September 30 the new Sigpak machines were still not in use.

“No one there knows how to work those machines,” one whistleblower said flatly.

***

NIKKI HALEY, LOU AND BILL KENNEDY
NIKKI HALEY, LOU AND BILL KENNEDY

WHAT’S NEXT?

For Nikki Haley, Nephron Pharmaceuticals has obviously served its purpose.  In addition to the campaign cash and private flights she received while running for office, the project helped cement her reputation as a successful “economic developer.”

She was able to take credit for “hundreds of new jobs” in 2011, and this summer she attended the company’s grand opening like a conquering hero – two events which featured tons of media attention but little in the way of actual journalism.

Haley faces the voters in three weeks, and her reelection is all but assured – in large part thanks to the way the local press applauds her crony capitalist exploits as opposed to investigating them.

So for the self-styled “Jobs Governor,” Nephron was a clear win.

For the company (and for the South Carolina taxpayers who have helped subsidize it), the future is less certain …

We’re not saying Nephron can’t overcome its rocky start and eventually make good on its promises, but it has put itself in a deep hole.  With competitors already owning 60 percent of the market for the medicines it makes, it stands to reason the company cannot afford to continue running at less than full capacity for much longer.

Personally, we hope Nephron succeeds … primarily because we’d hate to see millions of dollars in tax money flushed down the toilet with absolutely nothing to show for it.  But Nephron’s success or failure isn’t the issue here – the issue is whether taxpayers should have to assume the risk associated with it.

We maintain that no company – large or small – should ever be handed a competitive advantage courtesy of the taxpayers.  Whether such investments produce dividends or not, the process is inherently corrupt and unfair.

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43 comments

The Real Truth October 14, 2014 at 12:42 pm

New jobs for South Carolinians … lol. Anytime there is a decent job added in South Carolina, its taken by a transplant from another state who relocates to SC. Just look at the directors for DSS. The acting interim Director moved to SC for employment reasons.

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SC Political Digest October 14, 2014 at 12:46 pm

DSS is your idea of the Ideal job. Obama has trained his Dumb@$$#$ well.

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Smacks October 14, 2014 at 1:06 pm

Get your brain out the gutter. And stop editing your post after others react/respond. There’s no mentioning of DSS being the ideal job. Were you on a major drunk over the weekend that carried over to today? Don’t answer, we already know the answer to that question.

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guest October 14, 2014 at 1:37 pm

Woudn’t one have to be “drunk” ego and power to spend 4 million $$$$’s on a campaign with ZERO chance of winning and polling at 3%?

Don’t answer, we apparently already know the answer to that. :-)

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larry October 15, 2014 at 5:34 am

It is his money maybe he is trying to get our head out of the sand and trying to wake us up to what is going on around us.

guest October 15, 2014 at 9:10 am

In my opinion it shows the average voter a level of incompetence which is very easy to understand.

Not many citizens have several millions of dollars to throw in the trash or flush down the toilet.

SC Political Digest October 14, 2014 at 12:45 pm

Firstly: FITS detests the Kennedy’s because they are not Democrats.

Too much rehashing in the first 3-or-400 words to hold interest. If you have something NEW, don’t regurgitate the same old news to lead. That’s just Stupid, boring and demonstrates your lack of talent and experience..and likely an indicator you have NOTHING new.

Also: The 700 jobs were, and ALWAYS have been, over a FIVE to 10 year period.

As far as salary decline…under Obama salaries have been reduced all over the country by an average of 10%-or-more a household. That’s an ENORMOUS economic FAILURE of Obama. ENORMOUS. Unemployment is raging under Obama too.

Any company struggling now (Sears, Dick’s Sporting Goods, JC Penny, Bi-Lo, GM)..and the total American economy is in meltdown because of Obama’s horrible management.

And: If you REALLY want to get an idea of how STUPID FITS takes his idiots for, he writes: “Personally, we hope Nephron succeeds”….

Yeah: Like Obama hoped Bush succeeded in Iraq, so much he destroyed the enormous strides our soldiers secured, so that now ISIS will soon again be a World Threat again…LMAO…

You liberals DESERVE each other…I Don’t…

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vicupstate October 14, 2014 at 12:50 pm

.under Obama salaries have been reduced all over the country by an average of 10%-or-more a household.

Source?

If every company that is struggling is only doing so because of Obama, does that mean that every company that is succeeding is do so because of Obama?

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chicdownstate October 14, 2014 at 1:55 pm

Apparently not. RCP has Republicans picking up 8 seats including Kansas now with Tillis ahead and Brown even.

Obama has destroyed the Democrat Party for a generation.

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vicupstate October 14, 2014 at 7:49 pm

Dream on. Kansas is listed as a ‘tie’. Hagan and Brown are still ahead.

Iowa and Colorado are genuinely close and either one could go either way. Democrats did significantly better than the polling in both 2010 and 2012.

Perdue has been losing ground to Nunn in GA as well, and that was before he said he was ‘proud’ to outsource jobs overseas.

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read it and weep October 14, 2014 at 8:09 pm

Wrong.Roberts by 4%. Tillis by 3%. Brown a toss up and run off in Georgia with Perdue winning by 5% in that race. Same in LA.

8 seats in senate and your boy Brownback wins. 14 seats in house and repubs pick up 2 governorships.

vicupstate October 16, 2014 at 8:48 am

I don’t see the Tillis +3 poll anywhere including RCP.
The most RECENT poll has Nunn up 3 on Perdue and close to 50%.

If you cherry pick only the most GOP favaorable polls and ignore the rest, which is most of them, them you can draw those conclusions.

mamatiger92 October 14, 2014 at 2:16 pm

**crickets**

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truthmonger October 14, 2014 at 1:04 pm

Ok, $#!+ for brains, is Sic lying or telling the truth? Oh, and while there is NO QUESTION that Obama is a criminal and an incompetent, the issue HERE is HALEY and HER lack of leadership. I’m still waiting for the bitch to justify fighting to protect her husband’s Guard benefits while allowing disability benefits for public safety officers to be cut by 17% without so much as a comment, and retirement for many public safety officers to be cut dramatically. Could it be that she’s only worried about her OWN pocket?

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WW October 14, 2014 at 1:21 pm

The truth: Obama is an incompetent failure and a liar!
: Ohaley is an incompetent failure and liar!
They are one in the same!
Obama+Ohaley=Ocrap
O bola and O Ha lie= total failure, self aggrandizement , self interest, incompetence, malfeasance in office

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Dot 9 October 14, 2014 at 1:14 pm

You left out China in your rant. China owns the USA now. Obama and his goons brought about their change as an experiment gone bad. The USA should have reverted back to being more independent from other nations economies. It will take generations to undo what he has destroyed. Meanwhile, China has made it riches off the backs of Americans. So many riches, it is building up it’s military force for the sole purpose of running all over the USA and its war monger politicians – like McCain and Graham. So grab your ankles and be ready to get fucked. The USA has been sold out – used up – and on its way to a burial plot. Thanks to the greed of $$$$$$$$. Now, go back over to Liz’s report on Obola … post a few things to get her to react.

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send in the clowns! October 14, 2014 at 1:32 pm

lol!!!!Everytime Fits posts an “exclusive” and Ervin has a press conference Haley’s poll numbers go higher!!!

Ervin has spent over 4 MILLION $$$ (more than Haley spent in 2010) after lying to the voters and saying he was going to drain his 401k/annuity(?) of $108,000 to run for governor because neither major political party found him to be an acceptable candidate. What a fool.

You are right Tango..this article is boring and frankly you need a translator. My guess is Fits is gonna try and tie her to the Ebola virus before the election while Ervin holds another press conference announcing he is no longer a Democrat turned REpublican turned self identified independent republican turned independent REpublican running as an independent (vicupchuck’s latest bizzaro twist on the confused one) and has formed a partnership with Green Peace.

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WW October 14, 2014 at 3:32 pm

Written by one of the chief BOZOS!

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SC Political Digest October 14, 2014 at 4:34 pm

LOL…Now that’s funny.

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Smirks October 14, 2014 at 4:51 pm

No one deserves you, that’s for sure.

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Uncle Ream Us October 14, 2014 at 5:50 pm

Damn, Tango! You’d fuck the neighbor’s dog if it had a “R” on its collar.

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OJ Skimpson October 14, 2014 at 12:53 pm

I wonder if Trikki has had a turn with Lou,s flap jacks….Haley swingers club central.

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Flap,Flop, or Fapp jacks? October 14, 2014 at 4:27 pm

lol….a perfect description of her tits. Kudos to you.

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Robert October 14, 2014 at 1:28 pm

And they want a 1% tax increase in Lexington County with part of the money to get towards road work for Nephron??? No to the increase. No!

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mamatiger92 October 14, 2014 at 1:32 pm

and the morons in this state will overwhelmingly re-elect Haley next month. pathetic.

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euwe max October 14, 2014 at 1:36 pm

What SC needs is an outhouse factory.

Reply
Centrist View October 14, 2014 at 2:55 pm

FDA Warning letters to Nephron

Inspections, Compliance, Enforcement, and Criminal Investigations

http://www.fda.gov/iceci/enforcementactions/warningletters/2005/ucm075579.htm
Nephron Pharmaceuticals Corp 28-Sep-05

CERTIFIED MAIL
RETURN RECEIPT REOUESTED
WARNING LETTER
FLA-05-52
September 28, 2005
Mr. William P. Kennedy
President and COO
Nephron Pharmaceuticals Corp.
4121 SW 34th Street
Orlando, FL 32811-6475

Dear Mr. Kennedy:

The Food and Drug Administration (FDA) inspected your drug manufacturing facility located at the above address on March 21-28, 2005.

Our inspection found significant deviations from the Postmarketing Adverse Drug Experience (PADE) reporting requirements, within the meaning of 21 U.S.C. §355(k) [Sections 505(k) of the Federal Food, Drug, and Cosmetic Act (“the Act”)]. See also Title 21, Code of Federal Regulations (C.F.R.) Part 314 (21 C.F.R. §314). Based on our review of the establishment inspection report, we conclude that your firm violated Section 301(e) of the Act because you failed to comply with 21 C.F.R. § 314 and Section 505(k) of the Act.

Our inspection also found deviations from the current good manufacturing practice (CGMP) requirements for drug products, within the meaning of 21 U.S.C. §351 (a)(2)(B) [Section 501(a)(2)(B) of the Act]. See 21 C.F.R. Parts 210 and 211 (21 C.F.R. §§ 210-211). The CGMP deviations cause your products, Albuterol Sulfate Inhalation Solution, Ipratropium Bromide Inhalation Solution, Racepinephrine Inhalation Solution and Sodium Chloride Inhalation Solution, to be adulterated within the meaning of 21 U.S.C. § 351 (a)(2)(B) [Section 501(a)(2)(B) of the Act], in that the methods used in, or the facilities or controls used for, the manufacturing, processing, packing, storage or holding of the drug products are not operated or administered in conformity with CGMP. See 21 C.F.R. §§ 210-211.

Please note that we subdivided the warning letter to separately address the PADE deficiencies and the CGMP deficiencies.

A. Deviations from the PADE regulations include, but are not limited to the following:

1. Failure to develop written procedures for the surveillance, receipt, evaluation, and reporting of postmarketing adverse drug experiences to FDA [21 C.F.R § 314.80(b)].
(See letter for details.)

2. Failure to report adverse drug experience information to FDA [21 C.F.R. § 314.80(c)].
(See letter for details.)

3. Periodic adverse drug experience reports have not been submitted quarterly for one product which was approved less than three years ago and annually for three products that were approved three or more years ago [21 C.F.R. § 314.80(c)(2)].
(See letter for details.)

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm370008.htm
VIA UPS
w/ DELIVERY CONFIRMATION

WARNING LETTER
FLA-13-30
September 24, 2013

Lou Kennedy, CEO
Nephron Pharmaceuticals Corporation
4121 SW 34th Street
Orlando, FL 32811

Dear Ms. Kennedy:

This letter concerns your firm’s marketing of the over-the-counter (OTC) drug product Asthmanefrin (NDC 0487-2784), a bronchodilator containing the active ingredient racepinephrine hydrochloride. Asthmanefrin is marketed both in the Asthmanefrin Starter Kit, which contains 10 Asthmanefrin vials co-packaged with the EZ Breathe Atomizer, a continuous battery powered atomizer, and in the Asthmanefrin Refill, which contains 30 Asthmanefrin vials. The directions for use for Asthmanefrin, as provided on the labels of both the Asthmanefrin Starter Kit and Asthmanefrin Refill, state that the Asthmanefrin vials are to be administered via an atomizer such as the EZ Breathe Atomizer.

As labeled, Asthmanefrin is a drug within the meaning of sections 201(g)(1)(B) and (C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §§ 321(g)(1)(B) and (C)] because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and because it is intended to affect the structure or function of the body. Specifically, the product labeling, including the outer carton label for the Asthmanefrin Starter Kit and Asthmanefrin Refill, states that these products are intended for the temporary relief of mild symptoms of intermittent asthma, including wheezing, tightness of chest, and shortness of breath.

In addition, based on the active ingredient and the claims made for this product, Asthmanefrin is a “new drug” within the meaning of section 201(p) of the Act [21 U.S.C. § 321(p)] because it is not generally recognized as safe and effective for its labeled uses. Drug products intended for indications such as those for which Asthmanefrin is labeled have been evaluated and determined by FDA to be generally recognized as safe and effective under the final monograph for Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for OTC use, 21 CFR Part 341 (OTC bronchodilator final monograph).

The OTC bronchodilator final monograph, however, does not include racepinephrine hydrochloride for use as a bronchodilator using a continuous atomizer such as the EZ Breathe Atomizer.[1] See 21 CFR 341.76. Moreover, we are not aware of any other evidence establishing a product such as Asthmanefrin being generally recognized as safe and effective when directed for use with a continuous atomizer such as the EZ Breathe Atomizer.

Under sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless an application approved by FDA under either section 505(b) or (j) of the Act [21 U.S.C. § 355(b) or (j)] is in effect for the product. Based upon our information, there is no FDA-approved application on file for Asthmanefrin. The marketing of this product without an approved application constitutes a violation of these provisions of the Act.

Furthermore, the Center for Devices and Radiological Health has reviewed your website, http://www.nephronpharm.com/, and links on your website (http://www.ezbreatheatomizer.com/ and http://www.asthmanefrin.com/), and has determined that the EZ Breathe Atomizer is adulterated under section 501(f)(1)(B) of the Act [21 U.S.C. § 351(f)(1)(B)], because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act [21 U.S.C. § 360e(a)], or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act [21 U.S.C. § 360j(g)] for the uses for which the device is intended. The EZ Breathe Atomizer is also misbranded under section 502(o) the Act [21 U.S.C. § 352(o)], because your firm introduced or delivered for introduction into interstate commerce for commercial distribution this device, intended for a use different from the intended use of a legally marketed device in the generic type of device described under 21 CFR 868.5640 (Medicinal nonventilatory nebulizer (atomizer)), without submitting a premarket notification to FDA as required by section 510(k) of the Act [21 U.S.C. § 360(k)] and 21 CFR 868.9(a).

(See letter for more details.)

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nitrat October 14, 2014 at 8:43 pm

Sounds like SC didn’t do its ‘due diligence’ on this bunch.

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Gunga Din October 14, 2014 at 3:25 pm

The “Taj Mahal?” A tomb built with money extracted from the local population to honor an erotic Indian consort? Oh I get it…

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The Pyramids are next, slaves October 14, 2014 at 4:26 pm

Ha! Nicely done.

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Crony Capitalism FTW! October 14, 2014 at 4:05 pm

So basically, Bobby Hitt & Nikki Haley helped finance a failed start up with taxpayer money.

So not only do we see what happens when gov’t chooses who gets tax breaks and/or taxpayer money, instead of creating a level playing field via low taxes across the board for everyone, we also have to ask, “How many other failed “private” ventures have been funded with taxpayers dollars?”

I’ll bet it’s a huge number…but we’ll never know the extent because corrupt rats like Bobby Hitt & Nikki Haley will file 13 everything they can get their hands on.

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Rocky October 14, 2014 at 6:05 pm

Wil – a well done piece.

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Dotan October 14, 2014 at 6:40 pm

looks like a 38 GG — maybe that’s what blinded everyone

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TontoBubbaGoldstein October 14, 2014 at 7:52 pm

*monotone Homer Simpson voice*

“TBG believes anything those titties tell him…..”

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RHood2 October 14, 2014 at 7:03 pm

On the bad side, economic development cluster fuck, for all the reasons you list.
On the good side? Nice cleavage on the CEO there.

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BIN News Editorial Staff October 14, 2014 at 7:11 pm

Just like morons like sic(k) willie pawned MarkieMark Sanfraud and T’Rav the Snorter on S.C.

And, remember that sic(k) willie was behind Trikki NIkki at first.

Until she dumped him.

Ooooops. Sorry. Strike the word “behind.”

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LexCo October 14, 2014 at 9:35 pm

I never comment on this but whoever wrote this is extremely wrong on the facts.
1. Over 500 South Carolinians were put to work building this(with private money) no mention of that.
2 over 300,000,000 dollars paid to local contractors for labor and construction materials, no mention of that.
3. They just received one of their permits this week and will be inviting FDA in for inspection by the end of the year. ( no mention of this)
4. Over 100 people are currently employed and the plan is for over 700 people. Some people are making 45,000/year and some are making 100,000/year, which is why the jobs will eventually be averaging 70,000 year–hence the term average wage.(yet the author points out the low side)
5. It’s taken a couple of years to just build the building–they aren’t going to hire 700 people until they can actually make the product.(although they indirectly created jobs building their site)
6. The tax bill on Nephron will be in the millions over the next few years alone, yet the services they receive will cost a fraction of this–this helps keep taxes low for other citizens of the county.
7. This companies spin off jobs and economic impact will also be in the millions( like the construction) yet no mention.
All I’m saying is that I understand people’s opinions but there are some facts that were either unintentionally left off or just not reported because of lack of knowledge. Either there is deliberate message here(which is fine, unfair,imbalanced) or incompetence which is another issue. Either way, people should know that his is a great business to have in Lexington County.

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Bullshit! October 15, 2014 at 1:28 am

Some thoughts:

#1 & 2 were funded by a construction loan for the building. It was 99% likely put into a LLC so that if the whole operation folds it doesn’t affect the core business, so it wasn’t really an majory expenditure by Nephron.

#4 So are you prepared to stand firm in your claim that 100 people are currently working at that specific facility instead off 60-70 as reported in this story?

Even further, are you gonig to tell us that 350 of the 700 jobs there will be $100K/year jobs? lol….sorry…I have trouble believing that.

#6 Nephron will be paying taxes you say? Let’s take a look at Section 2.2 in Nephron’s FILOT agreement:

“The County and the Company acknowledge that pursuant to the Act, upon execution of this Agreement, no part of the Project will be subject to ad valorem property taxation in the State.”

So how long will Nephron be exempt from taxes?

“through the last day of the Property Tax Year which is the twenty-ninth year following such year.” (that’s AFTER all phase completion, meaning well over 30 years)

You, ARE FULL OF SHIT!

But, it gets better, your #7 claim is so rich it could be used for compost. Who is it that will benefit from these “spin off jobs” and “construction”?

“All investment in, and job creation at, the Project by the Company, by any of its Affiliates, including, without limitation, Nephron Pharmaceutical Corporation, LuLu Trucking, Inc., Loose Screw Construction, LLC, and Kenne
dy Campus LLC, and by any third party to the extent that the Company or any of its Affiliates utilizes the property funded by such third party pursuant to any financing, lease, license, or other access arrangement, shall, to the extent
permitted by law, count toward each investment and job requirement.”

So all this “spin off” and what not, Nephron affiliates…lol…not even SC companies.

Wanna guess who own’s “LuLu Trucking”? LMAO!

What a crock of shit.

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guest October 15, 2014 at 9:02 am

Relax.Nobody is listening or believing this “bullshit” from Fits.Look at the polls.

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me987654 October 16, 2014 at 4:40 pm

All that proves is that people are stupid. Southern states are some of the worst run in the nation yet they keep electing lunatics (I know, I live in NC where the current government has DESTROYED the school system and is proceeding to wreck the road system)

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JimT October 18, 2014 at 11:23 am

Since you seem to have so much inside information, it would be helpful if you addressed the issues raised in the article. The problems with cutting training on the equipment and not teaching unskilled employees about working in a sterile environment are legitimate and very troubling issues.

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mark October 15, 2014 at 9:50 am

Are these the same people that were in trouble for medicaid fraud? Are these the same that were fined hundreds of thousands as a result? Just asking.

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eff NPC October 15, 2014 at 1:33 pm

I never comment on these things, but as a former employee at Nephron I have to say that unfortunately for the taxpayers for SC (and for those seeking one of those purported 707 jobs), this is all SO true. I signed a 2 year employment contract but was fired after 6 months and told no reason as to why (any wrongful termination lawyers out there?), and I was one of the very few people hired on who actually had previous pharmaceutical manufacturing experience. They spend more money bringing up their Florida employees to fulfill jobs rather than hiring SC people. Even as an experienced worker in big pharma, I wasn’t making nearly the $71000 that Nephron claimed to pay as an average salary. They have stolen countless documents from TRC. The CEO is routinely verbally abusive to employees, creating the worst hostile work environment that I had ever seen. Needless to say, if other good employees weren’t fired for such inconsequential things as looking at the CEO the wrong way, they left on their own accord because they were way too ethical to work for such a company.

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