Precision Formulations, LP – FDA Warning Letter, May 19, 2011

On May 2-19, 2011, the FDA inspected Precision Formulations, LP, evaluating the manufacturing of dietary supplements including Braz a Vie Acai. The inspection revealed numerous violations of dietary supplement Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111), rendering products adulterated under Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Failure to verify dietary ingredient identity:** Specifically for (b)(4) used in Braz a Vie Acai, Lot # (b)(4), prior to use (21 CFR 111.75(a)(1)(i)). The company released the product before identity testing was completed. 2. **Failure to establish specifications:** Lacking component specifications for purity, strength, and composition (21 CFR 111.70(b)(2)), and finished product strength specifications for dietary ingredients in proprietary blends (21 CFR 111.70(e)). 3. **Inadequate Master Manufacturing Records (MMRs):** Not preparing MMRs for each batch size (21 CFR 111.205(a)) and missing required information such as identity/weight of dietary ingredients, theoretical yield, packaging descriptions, and written instructions for manufacturing and quality control (21 CFR 111.210).