Dietary Supplement Company Slammed By FDA For Failure To Comply With CGMP

Brower Enterprises was recently hit with a warning letter from the U.S. Food and Drug Administration (FDA) that excoriates them for violating Current Good Manufacturing Practices (CGMPs). The violation of CGMPs caused a number of Brower’s products to be adulterated within the meaning of the Federal Food, Drug and Cosmetic Act (the Act). Examples of violations of CGMPs included keeping written procedures for quality control operations, holding and distributing operations, returned dietary supplements, and product complaints. Additionally, Brower failed to comply with CGMPs because it did not hold reserve samples of each packaged lot and labeled supplement that it distributed. CGMPs applicable to dietary supplements can be found at 21 CFR 111. Dietary supplement manufacturers must be aware of and comply with these regulations. Developing appropriate policies and procedures and keeping them current is vital to avoiding FDA enforcement actions and civil liability.

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