Gaspari Nutrition, Inc. – FDA Warning Letter, Nov 1, 2010

The FDA inspected Gaspari Nutrition's Lakewood, NJ facility from September 27 to November 1, 2010, finding serious violations of Current Good Manufacturing Practice (CGMP) for dietary supplements (21 CFR Part 111). These violations render the firm's dietary supplement products adulterated under section 402(g)(1) of the Federal Food, Drug and Cosmetic Act. Key deficiencies included the failure to follow written procedures for reviewing and investigating product complaints, as required by 21 CFR 111.553. The firm also failed to ensure qualified employees reviewed product complaints and that quality control personnel approved investigation decisions, violating 21 CFR 111.560(a) and 111.560(b). Furthermore, the company failed to investigate product complaints, as mandated by 21 CFR 111.560(a)(2), citing an example of a consumer reporting bloody stools. The firm's November 10, 2010 response to the FDA-483 was deemed inadequate as it did not fully address the cited violations. Gaspari Nutrition is required to respond in writing within fifteen working days, detailing specific corrective actions, measures to prevent recurrence, and a status update on previously proposed actions. Failure to promptly correct these violations may result in enforcement actions, including product seizure and/or injunction.