FDA 483 - Granules Omnichem Private Limited - December 09, 2016

On January 9, 2016, the FDA issued a Form 483 to Granules Visakhapatnam, India, following an inspection. The inspection revealed significant deficiencies in the facility's quality control and manufacturing processes, indicating a lack of adherence to current Good Manufacturing Practice (cGMP) regulations.

Key observations included:

* **Inadequate Investigation of Discrepancies:** The firm failed to thoroughly investigate unexplained discrepancies and the failure of a batch or any of its components to meet specifications. For instance, investigations into out-of-specification (OOS) results for drug products were found to be insufficient, lacking comprehensive root cause analysis and effective corrective and preventive actions (CAPA). * **Insufficient Equipment Cleaning and Maintenance:** Procedures for cleaning and maintaining equipment were not adequately established or followed, raising concerns about potential cross-contamination and product quality. * **Poor Environmental Monitoring:** The environmental monitoring program was found to be deficient, failing to ensure appropriate control over the manufacturing environment, which is critical for sterile or low-bioburden products. * **Lack of Data Integrity:** Issues related to data integrity were noted, suggesting that data generated during manufacturing and quality control activities might not be reliable or complete. This included concerns about audit trails, data access controls, and the overall trustworthiness of electronic records.

These observations indicate a systemic breakdown in the facility's quality management system, potentially impacting the safety, efficacy, and quality of drug