Aspen Pharmacare Holdings Limited — FDA Warning Letter Findings

Your firm failed to 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)). Poor Aseptic Practices During the inspection of your facility, we observed poor practices and behaviors in ISO 5 areas during the manufacturing of sterile (b)(4) drug products. These poor practices included, but were not…

Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)). You did not establish an adequate system for monitoring environmental conditions on the “ (b)(4) ’ aseptic filling line. For example: You did not conduct viable monitoring of the air and surfaces in ISO 5 areas where an operator was continuously present removing fallen bottles. You did not place the non-viable particle monitoring…

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)). Your firm did not establish appropriate specifications or test your sterile over-the-counter (OTC)…

Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)). Your Production and QU did not review electronic raw data and audit trails to ensure data integrity prior to batch release. Your operators obtained and printed a passing result after multiple production filter integrity tests failed. Your operators did not…