Oasis Medical, Inc. — FDA Warning Letter Findings

Your firm failed to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and (d)). Your firm’s QU failed to adequately execute its responsibilities. This includes oversight of both internal and external manufacturing activities, including laboratory services. Regarding functions that occurred at your facility, the records and information you provided…

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. You also failed to establish and follow an adequate written testing program designed to assess the stability…

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 failed to ensure the use of reproducible manufacturing processes for the production of sterile ophthalmic drug products. You also lacked an ongoing program to establish stable manufacturing operations…

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 or not the batch has already been distributed (21 CFR 211.192). Your firm lacked meaningful investigations of failed sterility and bioburden test results. For example: Sterility Failure Your quality unit (QU) did not adequately investigate a failed sterility test result for your (b)(4) drug product, VISCO SHIELD…