FDA 483 - Tower Laboratories Ltd. - July 11, 2025

During an FDA inspection conducted from July 8-11, 2025, an unnamed manufacturing facility received a Form 483, identifying significant deviations from regulatory requirements. The observations primarily concern inadequate quality control and data management practices, indicating non-compliance with Good Manufacturing Practices (GMP). A critical repeat observation highlighted the firm's failure to thoroughly investigate out-of-specification (OOS) results and product discrepancies. The company's OOS procedure was deemed insufficient, allowing the invalidation of initial OOS results and the release of affected batches without scientifically sound root cause investigations or appropriate market action for failing stability batches. Further issues included deficiencies in laboratory controls. Several analytical methods used for stability testing were not scientifically demonstrated to be stability-indicating, lacking proper validation (e.g., mass balance or peak purity evaluations). Additionally, raw material identification using FTIR did not involve parallel analysis with current reference standards. Computer system controls also presented significant concerns, with analytical data lacking second-person review and audit trail verification before batch release. Generic administrator accounts enabled untraceable activities, and password sharing was a concern. Finally, the inspection noted a failure to perform essential finished product testing, such as dissolution, for certain effervescent products. The firm is obligated to address these findings and implement comprehensive corrective actions to ensure compliance and safeguard product quality and patient safety.