FDA 483 - Sun Pharmaceutical Industries Ltd. - August 31, 2018

FDA investigators conducted an inspection of Sun Pharmaceutical Industries Ltd. in Halol, India, from August 20 to August 31, 2018. The inspection resulted in a Form 483 with 11 observations, indicating significant deficiencies in the facility's quality system and manufacturing processes.

Key observations include:

1. **Failure to investigate discrepancies:** The firm did not thoroughly investigate unexplained discrepancies and failures of a batch or its components to meet specifications, including the failure of a batch to meet its release specifications. This suggests a lack of robust root cause analysis and corrective action.

2. **Inadequate written procedures:** There is a lack of adequate written procedures for production and process control, which are designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. This indicates a systemic issue with process definition and control.

3. **Insufficient equipment cleaning and maintenance:** Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent malfunctions or contamination that would alter the identity, strength, quality, or purity of the drug product beyond the official or other established requirements. This poses a risk of cross-contamination and product quality issues.

4. **Uncontrolled environmental conditions:** There is a failure to exercise appropriate controls over computer or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel. This points to potential data integrity issues