Torrent Pharma Inc – FDA Warning Letter, Apr 9, 2019

The FDA issued a Warning Letter to Torrent Pharma, Inc. following an inspection from March 11 to April 9, 2019, at their Levittown, Pennsylvania facility. The letter identifies significant violations of current good manufacturing practice (CGMP) regulations (21 CFR parts 210 and 211), rendering their drug products adulterated.

Key violations include: 1. **Inadequate Equipment Design and Maintenance (21 CFR 211.63):** The firm's water system was not adequately designed, controlled, or monitored, leading to contamination, including *Burkholderia cepacia*. Deficiencies included dead legs and threaded pipe connections. The firm used this inadequate system to produce drug products like rectal suppositories and oral solutions. The FDA found the firm's proposed temporary water system and remediation plan lacking in detail and assurance of quality. 2. **Failure to Thoroughly Investigate Discrepancies (21 CFR 211.192):** The firm failed to adequately investigate failing microbiological results from their water system, specifically regarding *B. cepacia* contamination. Investigations were not extended to potentially affected marketed batches in a timely manner, and the significance of water system design deficiencies was not adequately addressed.

Additionally, the firm's products, "PHENOBARBITAL ORAL SOLUTION, USP" and "HYDROCORTISONE ACETATE SUPPOSITORIES,