FDA 483 - Alkem Laboratories Limited - March 27, 2024

This FDA Form 483 details numerous observations from an inspection, indicating significant deficiencies in the facility's quality system and manufacturing operations.

Key issues include: * **Inadequate Investigations:** Failure to thoroughly review unexplained discrepancies, batch failures, equipment breakdowns, and recurring deviations. A complaint regarding mixed tablets (12 tablets of Tabs mg in a mg bottle) was concluded without effective recurrence prevention. Manufacturing alarms were not investigated, and their product impact was not assessed. * **Quality Unit and Procedures:** Responsibilities and procedures for the quality control unit are not written or fully followed. Change controls are not managed within specified timeframes. * **Training Deficiencies:** Employees lack training in their specific operations and GMP procedures. * **Computerized System Validation & Data Integrity:** Failure to adequately perform GxP and impact assessments for the Q-Sutra system (data acquisition for in-process testing). The firm performing Q-Sutra validation was not qualified or on the approved service provider list. Electronic data backup failures (including HITSRV-TEST) were not investigated. Controls for computer-acquired data and systems are insufficient, lacking assurance that changes and access are by authorized personnel. HMI alarms and audit trails for manufacturing/packaging are not backed up and are automatically erased. HMI data for a submitted exhibit batch (mg) was not backed up. PQ scripts were executed without protocol instructions. * **Facility & Equipment Maintenance/Cleaning:** Buildings