FDA gets tough on GMP failures
The regulatory agency has requested a permanent injunction against three New Jersey firms that manufacture supplements and protein blends, which were found to not be following current GMP regulations.
FDA inspectors, who visited the facilities on three separate occasions, said these were contaminated with rodents. In addition, the companies had failed to control allergen contamination and did not clean processing equipment.
The three firms under inspection were Quality Formulation Laboratories, American Sports Nutrition and Sports Nutrition International. Operations at all three companies were overseen by Mohamed Desoky, who also faces injunction.
Repeated deviations
FDA conducted three inspections at the facilities, and each time noted “deviations” from GMP standards, it said.
These included manufacturing and storing products in “filthy” conditions, with FDA investigators discovering live and dead rodents, as well as rodent urine and feces in the facilities.
In addition, the firms were manufacturing the products in conditions that may cause contamination with allergens. During one inspection, investigations found several of the companies’ products contained milk ingredients that were not declared on the labels.
The companies also failed to clean processing equipment between batches, said FDA.
“The companies promised to make corrections, but they failed to do so,” said the agency, prompting it to request the US Department of Justice to file a complaint for permanent injunction.
“The FDA will not tolerate companies that fail to provide adequate safeguards,” said Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs.
The complaint requests a court order to stop the companies and Desoky from manufacturing and distributing the products until needed corrections are made.
Shaking the regulatory baton
FDA is in the process of stepping up inspections at supplement manufacturing facilities, after the second and largest round of companies were required to become GMP compliant last month.
The final rule of the GMP legislation was passed last year in an effort to provide standards specific to supplements for purity, safety and legality in manufacturing. Big companies (over 500 employees) had to implement the new standards in June last year. Mid-sized firms (20-499 employees) were required to become compliant last month, while small firms (less than 20 employees) have until June 2010 to comply.
FDA recently told NutraIngredients-USA.com that it will aim to inspect 200 facilities this year.
“It’s impossible for us to get to everybody this year. We will get to a large number, I can’t tell you exactly because I can’t predict work planning in the district nor can I predict the emergencies that always seem to come up for FDA. But our plan is to do a substantial number, like as many as 200 firms this fiscal year. It’s a very short time so I doubt we’ll hit it but we will try very hard,” said the agency’s manager of the Division of Dietary Supplements, Brad Williams.
He also suggested that if a firm passes a GMP inspection, it would be unlikely to face another one for several years.
“If we find problems, the first thing we do is we list our observations. Many times, that’s the end of the line. That’s good for us and that’s good for you because then we’ll go away and not bother you for two years. Sometimes, we have to shake a stick. Depending on what we find, it’s a big stick or a little stick.”
