cGMP Enforcement Actions Escalating in the United States

July 30, 2012 By

By Heather VanBlarcom
General Counsel & Senior Regulatory Specialist for Dietary Supplements

On July 16, 2012, the U.S. Food & Drug Administration (FDA) filed an injunction against a New York based supplement manufacturer for repeatedly violating dietary supplement current good manufacturing practices (cGMPs). In 2010, the company received a FDA warning letter citing numerous infractions including: ignoring product complaints and failing to do identity testing on its finished products. This is the second time that the FDA has filed such an injunction for GMP noncompliance against a dietary supplement company.

“I think GMP noncompliance sends a message,” Daniel Fabricant, head of FDA’s Division of Dietary Supplement Programs, told Nutrition Business Journal in June. “Roughly 35 percent of inspections come in from the districts classified as ‘official action indicated,’ which means that we’re going to move toward a warning letter or a stronger action, maybe pursue something with the Department of Justice that has an injunction or seizure attached to it. Another 35 percent is roughly classified as ‘voluntary action indicated,’ which means that the firm could self-correct or the investigator didn’t gather all the evidence needed to proffer a warning letter. That’s 70 percent, the majority of firms we’ve visited.”

There is no excuse for failing to take the necessary action in response to an FDA Form 483 or a warning letter. dicentra has all the necessary resources to help you achieve compliance with 21 CFR 111. FDA is not backing down. They will return to your facility and will not hesitate to take further enforcement action.


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