Similasan AG — FDA Warning Letter Findings

Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards. (21 CFR 211.194(a)) Your laboratory records do not include complete testing data to support the analysis performed. For example, negative controls for sterility testing are not documented at the time of performance. The absence of concurrently performed negative controls during sterility testing does…

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 211.22(d)). Your quality unit (QU) did not provide adequate oversight for the manufacture of your drug products. For example, your QU failed to ensure: • Adequate procedures for that are designed to prevent microbiological contamination of drug products purporting to be sterile (21…

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)) The written procedures for your media fills were not appropriate because they failed to accurately simulate commercial manufacturing. Our inspection found that aseptic interventions simulated during your media…

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. (21 CFR 211.160(b)) You failed to establish and conduct 100% visual inspections of your ophthalmic drug products to…