"FDA Hits Gaspari Nutrition"

[MattyH7688]

http://supplementgenius.com/consumer...ari-nutrition/
Gaspari Nutrition is the latest firm to be in breach of Good Manufacturing Practice (GMPs), regulations after inspections in 2010 revealed adverse event reporting (AER) breaches. The FDA ‘483′ inspections that occurred over a five week period between September 27 – November 1, 2010, found the maker of PlamaJet and SuperPump products did not follow its own AER procedures in regard to seven separate complaints. For those two products, the FDA said the company did not perform analysis of the complaints it classified as “minor discomfort”. For a product called Mitotropin, complaints were classified as “Serious Personal Injury Claims”, but Gaspari did not have them, “referred to the Senior Manager of Distributor Services or have the Senior Manager interview the complainants, as called for in your firm’s written procedures.” There was also a Serious Personal Injury complaint for SuperPump. Gaspari responded to the FDA in November, 2010, saying it was rectifying the problem, but the FDA said the problems had not been resolved and added that it would be evaluating, “whether your firm has established and followed written procedures for reviewing product complaints during our next inspection.”

Blood In Your ****?

The Adverse Event Reports included sores inside a consumer’s mouth, as well as, “chest pain and abnormal kidney levels” after product consumption. Gaspari also, “did not investigate the complaint of a consumer who contacted your firm regarding having bloody stools and excessive amounts of red color in their toilet water following consumption of your SuperPump dietary supplement product.”

A Gaspari spokesperson said the company had no comment on the letter.

[tacubaya]

[jorgemontenegro]

in for spicey

[Eyayo]

i **** blue when i drank nano vapor, and when i eat captin crunch berries. Doubt its blood.

[Handcannon7]

lmao i feel like the blood in stool complaint is a troll

[em-dubya]

In b4 deletion.

[sloop]

In b4 quank!
In b4 lock & delete!

[SwolenONE]

eh, ill sub for some ensuing lulz, why not.

[Vitruvian]

There are no ulterior motives present in this thread.

[MattyH7688]

There are no ulterior motives present in this thread.

I saw this on another forum.. I am going to best honest, I could really give two ****s about Gaspari or the drama anymore. I just posted this article. I don't work for another supplement company and was not told to post this by anyone.

[quank]

In b4 quank!
In b4 lock & delete!

[DJNY24]

http://www.fda.gov/ICECI/Enforcement.../ucm246818.htm

its right on the FDA website this isnt bull. Stuff like this is bound to happen, most of these products arent FDA approved. Hell even products that are FDA approved sometimes turn out to be deadly. If you just read the claims on these products any person with a brain can realize that they cant be 100% good for you, lol

[Archanic]

spot for sale on soon to be huge thread / debate.

[eldawg]

I think that as (FDA) oversight and enforcement increases, we are likely to see a lot more of these notices across the industry.

[Tru3demon]

First page

[GymRat128]

It didnt earn the nick-name SuperDUMP250 for no reason....

[deserusan]

I think that as (FDA) oversight and enforcement increases, we are likely to see a lot more of these notices across the industry.

Yes you will. We've hired a MD, MPH and have a quality assurance staff managed by someone who formally worked for Merck (she's a chemical engineer). GMP's are extremely serious and while we try our best, we aren't perfect although we strive to be in this new regulatory environment. From what I've seen a lot of companies are getting in trouble for quality control issues of their products which to me is a bigger issue. Either way, the FDA is cracking down on the supplement industry whether you are big or small.

[MeatFlaps]

Wow. And i thought the squirts were bad enough. But bloody squirts? Gain huge amounts of mass while getting bloody squirts and herpes. Sign me up.

[xStevenx]

wow first page

[d4nny3]

in b4 2nd page

[DedicatedDad]

Interested to see where this goes.....

[68Mustang]

Yes you will. We've hired a MD, MPH and have a quality assurance staff managed by someone who formally worked for Merck (she's a chemical engineer). GMP's are extremely serious and while we try our best, we aren't perfect although we strive to be in this new regulatory environment. From what I've seen a lot of companies are getting in trouble for quality control issues of their products which to me is a bigger issue. Either way, the FDA is cracking down on the supplement industry whether you are big or small.

And which companies would those be?

[Massicio]

1st page?

[Mr.Cooper69]

interesting....

[Hipstir]

I know the FDA is cracking down on supplement companies. What would you say if I told you 8.6 out of 10 products don't meet label claims? Not just dosages, ingredients. GMP isn't the problem. That's broken by every company in the business. The problem is the unsafe manner in which these products are marketed. That's what drew our attention. Selling potentially dangerous unproven and ineffective supplements to impressionable uneducated idiots while not meeting label claims is a CLEAR violation of the law. Just wait until you see what goes down this May.

[maximizer]

It didnt earn the nick-name SuperDUMP250 for no reason....

this

[Hipstir]

And if supp reps think they have their asses covered, guess again. A conspiracy case is prepared involving several large companies.

[UncleWade]

Welcome to the rodeo.

[deserusan]

And which companies would those be?

Follow the FDA on Twitter or get on their e-mail list. They are doing a great job informing the public via the web/social media of their enforcement activities.

[Webber91]

1st page