FDA WARNING_LETTER - Pinnacle Labs International, Inc. - May 01, 2013

The FDA issued a Warning Letter to Pinnacle Labs International, Inc. following an April 11 to May 1, 2013, inspection of their dietary supplement manufacturing facility. Significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111) were found, causing products to be adulterated under section 402(g)(1) of the Act. Several products were also deemed misbranded under Section 403 due to labeling deficiencies. CGMP violations included failure to verify finished dietary supplement batches meet product specifications (21 CFR 111.75(c)), failure to conduct identity testing for dietary ingredients prior to use (21 CFR 111.75(a)(1)(i)), and failure to confirm non-dietary ingredient identity or qualify suppliers (21 CFR 111.75(a)(2)). Additionally, batch production records (BPRs) lacked required elements like equipment identity, unique component identifiers, actual yield, finished product specification documentation, and proper quality control reviews and approvals (21 CFR 111.260). Misbranding violations involved product labels failing to identify products as "dietary supplements" (21 CFR 101.3(g)), lacking a domestic address/phone for adverse event reporting (Section 403(y)), failing to declare all ingredients by common name (Section 403(i)(2)), not identifying plant parts for botanicals (21 CFR 101.4(h)(1)), and omitting manufacturer/distributor information (21 CFR 101.5). The firm's responses were inadequate. Pinnacle Labs must promptly correct all violations and prevent recurrence within fifteen working days. Non-compliance may result in legal action, including seizure or injunction, and re-inspection fees.