Absolute Packaging, Inc. – FDA Warning Letter, Apr 9, 2010

On September 9, 2010, the FDA issued a Warning Letter to Absolute Packaging, Inc. following an inspection from March 24 to April 9, 2010. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals (21 CFR Parts 210 and 211), rendering their drug products adulterated. The firm also manufactures OTC drug products that violate sections 502 and 505 of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Lack of Quality Control Unit Procedures:** The firm failed to establish or follow written procedures for its quality control unit (QCU), specifically regarding the approval of master formulas and product labeling for OTC products like "Aloe Gel (Pain Relief.cc TM)" and "Aloe Gel (Burn Relief)." For example, two different master formulas were used for Burn Relief without QCU approval, and one formula omitted a labeled ingredient (tocopheryl acetate). 2. **Unapproved Procedures/Specifications:** The QCU did not approve or reject procedures or specifications for containers, closures, packaging materials, and labels. Additionally, two SOPs lacked QCU approval and dates. 3. **Inadequate Production and Process Controls:** The firm lacked adequate written procedures for production and process controls, specifically failing to perform process validation for filling, labeling, and packaging OTC drug products. 4. **