Cosmetic Specialty Labs, Inc. — FDA Warning Letter Findings

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 manufactures over-the-counter (OTC) drug products, such as pain relievers, hand rubs (also referred to as a consumer hand sanitizer), and sunscreens. Your firm failed to establish an adequate quality unit (QU) to appropriately oversee…

Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)). You have not demonstrated that your cleaning practices are adequate to remove contaminants from the shared equipment used to manufacture your OTC drug products. Inadequate Cleaning Validation You have not demonstrated that your 2003 cleaning validation study is adequate to ensure your cleaning procedures are effective for the multiple OTC drug…

Your firm failed to establish adequate 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 lacked appropriate process validation for your drug products. For example, the process validation protocol for your (b)(4) drug product lacked microbiological testing and the active ingredient…

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 21 CFR 211.84(d)(2)). You failed to adequately test your incoming components for identity before using the components to manufacture your drug products. Additionally, you relied on your suppliers’ certificate of…