FDA 483 - AMMAN PHARMACEUTICAL INDUSTRIES - August 15, 2023

An FDA inspection conducted at Amman Pharmaceutical Industries from August 7-10 and 13-15, 2023, identified significant deficiencies in the firm's manufacturing practices for sterile drugs, laboratory controls, and quality systems. The primary violations cited under the FDA 483 regulatory framework relate to numerous instances of poor aseptic technique, directly compromising sterile product integrity. Operators were observed with exposed skin, reaching over sterile components, failing to disinfect hands, and improper use of tools, violating procedures for preventing microbiological contamination. Further issues included inadequate validation of aseptic processes, with smoke studies lacking dynamic conditions and media fills failing to reflect routine interventions. Laboratory records were found to be incomplete and inaccurate, with samples documented but not collected, incorrect colony counting, and a failure to record or investigate numerous environmental monitoring excursions. Environmental monitoring itself was deficient, lacking critical surface monitoring, adequate personnel monitoring, and proper microorganism identification. Other observations highlighted a lack of machine cleaning, inadequate disinfectant efficacy studies, incomplete batch production records that did not capture critical interventions, and inaccurate data entries. Chromatographic data integrity was compromised by inappropriate integration parameters, lack of audit trail review, and overwritten data. The firm also failed to thoroughly investigate discrepancies and ensure proper supplier qualification for active pharmaceutical ingredients. Equipment design was found unsuitable for aseptic conditions. These findings necessitate immediate and comprehensive corrective and preventive actions from Amman Pharmaceutical Industries to ensure drug product quality and patient safety.