FDA 483 - Cipla, Ltd. - May 06, 2024

An FDA inspection of Cipla Ltd., an API and Finished Dosage Manufacturer in Kurkumbh, Maharashtra, India, identified a significant lapse in their quality system. The firm failed to fully follow the responsibilities and procedures applicable to its quality control unit. Specifically, uncontrolled "SAMPLE LOCATION CHART" documents were found in use for stability samples within multiple stability chambers, indicating a failure to adhere to established document control procedures.