Episciences Inc. — FDA Warning Letter Findings

Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether the batch has already been distributed (21 CFR 211.192). Your investigations into out-of-specification (OOS) laboratory results are inadequate because they do not include scientifically supported conclusions and lack corrective actions and preventive actions (CAPA). For example: A. Your investigation into bulk 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, and to follow all of your written production and process control procedures (21 CFR 211.100(a) & 211.100(b)). You failed to adequately validate the drug manufacturing processes for your Over-the-Counter (OTC) drug products. For…

Your firm failed to perform, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release, and for each batch of drug product required to be free of objectionable microorganisms, appropriate laboratory testing, as necessary (21 CFR 211.165(a) & 211.165(b)). You failed to perform adequate release testing for each…

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) & 211.84(d)(2)). You did not perform identity testing on each component lot prior to use in manufacture of your drug product. Several API lots were released into production without performing adequate acceptance testing…