FDA WARNING_LETTER - Oza Compound Products, LLC - January 19, 2012

On June 7, 2012, the FDA issued a Warning Letter to Oza Compound Products, LLC, following an inspection from January 18-19, 2012, which revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111). These violations render the Oza Compound dietary supplement product adulterated under section 402(g)(1) of the Federal Food, Drug and Cosmetic Act (the Act).

Key CGMP violations include: 1. Failure to establish identity, purity, strength, and composition specifications for components and finished dietary supplements (21 CFR 111.70). 2. Batch production records (BPRs) lacking complete information, such as equipment identity, cleaning dates, monitoring results, testing results, documentation of meeting specifications, and initials of personnel performing and verifying steps (21 CFR 111.255(b), 111.260). 3. Master Manufacturing Records (MMRs) failing to identify control points and lacking corrective action plans for when specifications are not met (21 CFR 111.205(b)(1), 111.210). 4. Failure to establish written procedures for quality control operations, including material review and disposition decisions (21 CFR 111.103).