Cerebral Health, LLC – FDA Warning Letter, Feb 18, 2011

On May 23, 2011, the FDA issued a Warning Letter to Cerebral Health, LLC, following an inspection from February 8-18, 2011. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for Dietary Supplements (21 CFR Part 111), rendering their products adulterated under Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. Failure to prepare and follow written master manufacturing records (21 CFR 111.205(a)). 2. Failure to establish product specifications for finished dietary supplements (21 CFR 111.70(e)). 3. Failure to establish identity specifications for dietary ingredient components (21 CFR 111.70(b)(1)). 4. Failure to conduct identity testing for dietary ingredient components (21 CFR 111.75(a)(1)). 5. Failure to establish and follow written procedures for quality control operations, including material review and disposition (21 CFR 111.103). 6. Failure to prepare and keep batch production records (21 CFR 111.255). 7. Failure to establish and follow written procedures to review and investigate product complaints (21 CFR 111.5