FDA 483 - Torrent Pharmaceuticals Limited - April 16, 2019

FDA Form 483 was issued to Torrent Pharmaceuticals Ltd. in Indrad, India, following an inspection that concluded on April 16, 2019. The inspection revealed significant deficiencies in the facility's quality control unit and manufacturing processes, indicating a lack of adherence to current Good Manufacturing Practice (cGMP) regulations.

**Key Observations:**

1. **Inadequate Investigation of Discrepancies:** The quality control unit failed to thoroughly investigate unexplained discrepancies and the failure of a batch or its components to meet specifications. Specifically, the firm did not adequately investigate out-of-specification (OOS) results for stability samples of Valsartan/Amlodipine Besylate tablets, which showed an increasing trend in an unknown impurity. The investigation was closed without identifying a root cause, and the firm continued to release batches.

2. **Insufficient Cleaning Validation:** Procedures for cleaning and maintenance of equipment were not established and followed. The firm failed to adequately validate cleaning procedures for multi-product equipment, specifically for the Valsartan/Amlodipine Besylate tablets. The cleaning validation did not include sufficient data to demonstrate that residues were consistently removed to acceptable levels, particularly for the active pharmaceutical ingredient (API) Valsartan, which was found to be a potential source of the unknown impurity.

3. **Lack of Written Procedures for Production and Process Control:** There was an absence of written procedures for production and process control designed to assure that drug products have