FDA 483 - APIPHARMA d.o.o - March 28, 2025

During an FDA inspection conducted from March 24-28, 2025, several critical observations were noted at the firm, highlighting significant non-compliance with current Good Manufacturing Practices (cGMP) for drug products. The inspection revealed substantial deficiencies across the quality system, laboratory controls, and production processes, particularly concerning Over-the-Counter (OTC) ointment products. Key issues included a widespread failure in data integrity, with the Quality Unit unable to provide original raw data and calculations for final product release and stability testing. Electronic records were deemed untrustworthy, lacking audit trail capabilities, and a forged Quality Assurance Head's signature was identified on a stability study. Laboratory control weaknesses encompassed inadequate stability testing programs, including unsuitable storage conditions without proper temperature mapping, and the absence of essential Standard Operating Procedures for HPLC system suitability and microbiological testing. Furthermore, the firm failed to establish appropriate final product testing specifications, notably for impurity testing, without scientific justification. Production and process control deficiencies included incomplete process validations, a lack of hold time studies for critical equipment, and missing yield reconciliations. A customer complaint regarding a product color discrepancy was also inadequately investigated. The firm is required to undertake comprehensive corrective and preventive actions to address these systemic issues, ensuring the reliability of its data, the robustness of its quality control, and the overall compliance of its manufacturing operations with regulatory standards.