K.C. Pharmaceuticals Inc. — FDA Warning Letter Findings

Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)). Cleaning validation studies for aseptic processing line (b)(4) , used to manufacture multiple formulations of ophthalmic drug products, has not been completed. For example, the (b)(4) compounding tank and product transfer line (b)(4) , used to formulate bulk ophthalmic drugs for filling on line (b)(4) , did not have recovery studies or limits of…

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 includes validation of all aseptic and sterilization processes (21 CFR 211.113(b)). Smoke Studies Your smoke studies for your aseptic processing lines were not performed under conditions that adequately simulate actual manufacturing. For example, the smoke study performed in 2018 did not…

Your firm failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas (21 CFR 211.42(c)(10)). Your aseptic processing operation is inadequately designed to prevent contamination of your ophthalmic drug products. For example, your firm lacked adequate building management systems (BMS) to monitor and record…