Optikem International Inc. — FDA Warning Letter Findings

Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)). Inadequate Process Simulation You produced and distributed drug product purporting to be sterile without first conducting adequate process simulations (e.g., media fills), including but not limited to…

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)). You failed to adequately validate the manufacturing processes used for the production of your sterile ophthalmic drug product. You also lacked validation of the (b)(4) water system that produced water used in…

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 conform to appropriate standards of identity, strength, quality, and purity, and conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.160(b) and 211.165(b)). Your firm failed to…

Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated (21 CFR 211.22(a)). Your quality unit (QU) did not adequately exercise its…