Amman Pharmaceutical Industries — 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 lacked complete and trustworthy data to support the analyses performed. For example: Laboratory records were unreliable including discrepant and missing data. These laboratory records included, but were not limited to, microbiological samples collected from…

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)). Inadequate Process Simulation Your firm failed to establish adequate written procedures designed to prevent microbiological contamination risks in your facility, and to ensure that such procedures were followed…

Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)). Your QU did not adequately exercise its authority and responsibilities, including but not limited to, implementing effective procedures, and conducting adequate oversight. For example, your QU failed to: Ensure that…