bB BIOCHEM LABORATORIES INC. – FDA Warning Letter, Dec 18, 2017

The FDA inspected bB BioChem Laboratories Inc. from December 12-18, 2017, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated. Additionally, Medicated Pain Relieving Oil Extra Strength and Medicated Pain Relieving Oil Sensitive Strength were deemed unapproved new drugs.

Key violations include: 1. **Lack of finished product testing:** The firm released OTC drug products without adequate quality control testing for identity and strength of active ingredients, and lacked finished product specifications (21 CFR 211.165(a)). 2. **Inadequate component testing:** The firm failed to test incoming raw materials for identity, strength, and other attributes, relying on unqualified supplier COAs, and lacked written specifications for raw materials (21 CFR 211.84(d)(1) and (2)). 3. **No stability program:** The firm lacked a stability program and data to support the three-year expiration dates for their drug products (21 CFR 211.137(a)). 4. **Absence of a quality control unit:** The firm lacked a quality unit with defined responsibilities and authority, and failed to establish systems for basic drug manufacturing operations like change control, complaints, and supplier qualification (21 CFR 211.22(a)).

The FDA recommends engaging a qualified consultant to address these CGMP issues