Sun Pharmaceutical Industries Limited – FDA Warning Letter, Dec 15, 2023

The FDA issued a Warning Letter to Sun Pharmaceutical Industries Limited following an inspection from December 4-15, 2023, at their Dadra, India facility. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated.

Key violations include: 1. **Inadequate Equipment Cleaning and Maintenance (21 CFR 211.67(a))**: An investigator found approximately 450 mL of stagnant, contaminated liquid in a non-dedicated piece of equipment used for over 40 different drug products. Chemical analysis showed numerous unknown peaks, and microbiological analysis identified high microbial counts, including *Sphingomonas paucimobilis*, *Bordetella bronchiseptica*, and *Pseudomonas stutzeri*. The company attributed this to a faulty valve, leading to the recall of 12 batches and rejection of 20 batches. The FDA deemed the response insufficient due to incomplete characterization of unknown peaks and inadequate assessment of the equipment maintenance program.

2. **Inadequate Investigation of Discrepancies (21 CFR 211.192)**: The firm failed to thoroughly investigate out-of-specification (OOS) results, specifically an unknown impurity in stability samples. Initial investigations lacked scientific justification, with root causes incorrectly attributed to dirty glassware and then to contamination from another product. The FDA found the company's subsequent identification of the impurity as (