Brand Packaging Group, Inc. – FDA Warning Letter, Apr 8, 2022

The FDA inspected a dietary supplement facility at 75 & 85 Price Parkway, Farmingdale, NY, from March 29 to April 8, 2022, revealing significant Current Good Manufacturing Practice (CGMP) violations under 21 CFR Part 111. These violations render products, including (b)(4) and (b)(4), adulterated.

Key violations include: 1. **Failure to verify finished product specifications (21 CFR 111.75(c)):** The firm relied on production input for assay testing instead of analytical testing of finished products. The response was inadequate as it lacked specifications and test methods for microbiological testing. 2. **Failure to verify dietary ingredient identity (21 CFR 111.75(a)(1)(i)):** No testing was conducted on new dietary ingredients upon receipt; the firm used (b)(4) and (b)(4) for initial testing and as a standard. The adequacy of corrective actions, including purchasing a scientific database, could not be evaluated. 3. **Failure of quality control to reject non-conforming components/products (21 CFR 111.77(a), 111.113(b)(2)):** Ingredients like (b)(4) and (b)(4) did not meet identity specifications but were used without QC investigation. Corrective actions, such as SOP revisions