Aerosol and Liquid Packaging, Inc. — FDA Warning Letter Findings

Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)). Your firm contract manufactures over-the-counter (OTC) drug products, including skin and wound cleanser drug product (b)(4) Topical Antiseptic Spray. You failed to test incoming active pharmaceutical…

Your firm failed to establish written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)). Your firm failed to adequately qualify the equipment and validate the processes used to manufacture the (b)(4) Topical Antiseptic Spray drug product. You have not performed process performance qualification (PPQ) studies…

Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)). Your firm manufactures OTC drug products and industrial-grade products (e.g., laundry detergents) on non-dedicated…

Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22). Your firm failed to establish an adequate quality unit (QU) with the responsibilities and authority to oversee the manufacturing of drug products. For example, you failed to ensure: Laboratory records include complete data derived from all tests…