FDA WARNING_LETTER - Brands International Corporation - June 21, 2024

The FDA issued a Warning Letter to Brands International Corporation following an inspection from June 17-21, 2024, at their Newmarket, Ontario, Canada facility, citing significant Current Good Manufacturing Practice (CGMP) violations. The firm's drugs are deemed adulterated under 21 U.S.C. 351(j) due to limiting and delaying the inspection, including hostile behavior by management, interference with investigators, and withholding requested records (e.g., complaints, distribution lists).

Additional CGMP violations include: 1. **Inadequate Investigations (21 CFR 211.192):** Failure to thoroughly investigate customer complaints, specifically mold contamination in "Kissable Oatmeal Daily Moisturizing Body Lotion," and not adequately extending the investigation scope. 2. **Insufficient Product Testing (21 CFR 211.165(a)):** Releasing drug products without adequate testing for identity and strength of active ingredients, and using unvalidated test methods. 3. **Inadequate Component Testing (21 CFR 211.84(d)(1) and 211.84(d)(2)):** Failure to test incoming components, including APIs, for identity, and not validating supplier COAs. Concerns were raised about testing for Diethylene Glycol (DEG) and Ethylene Glycol (EG) in high-risk components like glycerin. 4