| In
the wake of a new administration, the FDA filed an injunction at the
New Jersey District Court on July 1st against Quality Formulation
Laboratories, Inc., American Sports Nutrition, Inc., American Sports
Nutrition International, LLC and Mohamed S. Desoky for failing to
meet GMP requirements for manufacturers. Desoky, an executive representative
of all three companies was also named in the case because he oversees
the daily operations. Over a series of investigations of their facilities
for more than 2 years which resulted in unfavorable reports, the FDA
made a bold move to file suit.
This stands to set precedent when it comes to what
the FDA will do to manufacturers who are not in GMP compliance.
From warning letters and periodic facility monitoring, to court
injunctions, the FDA has moved into a new phase of cracking down
on manufacturers who fail to meet the GMP compliance deadlines.
| Company Size |
GMP Deadline |
| 500+ employees |
June 2008 |
| 20-499 employees |
June 2009 |
| Less than 20 employees |
June 2010 |
Investigative reports of the companies sited allergen
contamination, unclean processing equipment, mislabeling and undeclared
ingredients as some of the GMP compliance failures, which were not
corrected in a timely manner or by the FDA deadline request. Although
these companies were repeat offenders, the FDA has made public statements
about moving forward with future investigations of more manufacturers
for GMP compliance.
“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.
Sources: www.dockets.justia.com | www.fda.gov
|
