FDA 483 - Alembic Pharmaceuticals Limited - November 22, 2024

A recent FDA inspection of Alembic Pharmaceuticals Limited, an India-based finished product manufacturer, from November 14 to November 22, 2024, resulted in the issuance of a Form FDA 483 detailing significant observations. The primary concerns revolve around the firm's adherence to Good Manufacturing Practices (GMP) and data integrity. Key violations included inadequate control procedures for manufacturing processes. Specifically, Critical Process Parameters (CPPs) were not consistently identified or justified with empirical data in process performance qualification (PPQ) reports and batch records. The firm also failed to conduct proper process performance evaluations in Annual Product Quality Reports, even when sufficient data was available, and neglected to assess chemical residue levels during cleaning validation for multi-batch equipment. Further issues highlighted deficiencies in quality control, where acceptance criteria for sampling and testing lacked adequate statistical justification, particularly for contamination risk assessments of released products. Equipment cleaning verification procedures were found to be insufficient, lacking defined acceptable residue limits. Analytical method validation reports were deficient, missing crucial system suitability criteria. Significant data integrity concerns were also noted, including a lack of proficiency among personnel in auditing computer system data, undocumented reasons for unlocking data folders, discrepancies between equipment usage logs and actual history, and the storage of critical batch records on an individual's computer rather than a controlled system. Alembic Pharmaceuticals is required to promptly address these observations by implementing comprehensive corrective and preventive actions to ensure full compliance with FDA's cGMP regulations.