Cosco International, Inc. — FDA Warning Letter Findings

Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (211.160(b)). You lacked appropriate sampling and testing to ensure the (b)(4) water used as a component in your 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)). Lack of Process Validation You manufacture over-the-counter (OTC) drug products including topical drugs intended for wound treatment in children. You failed to adequately validate your manufacturing processes to…

Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products (211.166(a)). Your firm did not have adequate stability data to demonstrate that the chemical and microbiological properties of your drug products met established specifications and remain acceptable throughout their labeled shelf-life. For example, you distributed drug products intended for wound treatment in children without…

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 quality unit (QU) did not provide adequate oversight for the manufacture of your drug products. For example, your QU failed to ensure the following: Establishment of an adequate stability program (21 CFR 211.137). Establishment of adequate…