International Medication Systems Limited — FDA Warning Letter Findings

Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance (21 CFR 211.63). Your (b)(4) system was inadequately designed, monitored, and maintained. You use (b)(4) for cleaning drug manufacturing equipment, and the same system feeds your (b)(4) system. During the inspection, we…

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 manufactures active pharmaceutical ingredients and sterile injectable drug products. The sterile injectable products include aseptically filled (b)(4) . Your firm failed to conduct adequate investigations. For example, you inadequately…

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. Your firm also 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…