FDA WARNING_LETTER - Teligent Pharma, Inc. - May 20, 2019

The FDA inspected Teligent Pharma, Inc. in Buena, NJ, from April 22 to May 20, 2019, identifying significant CGMP violations, rendering their drug products adulterated. The firm also failed to submit required NDA Field Alert Reports (FARs).

Key violations include: 1. **Inadequate Investigations (21 CFR 211.192):** The firm failed to thoroughly investigate OOS results in a timely manner, justify root causes, expand investigations, implement CAPAs, or evaluate CAPA effectiveness. Examples include clobetasol propionate lot 8922, which had OOS impurity results at release and two stability intervals but no market action, and flurandrenolide ointment lots 8071 and 8072 with failing related compounds results. 2. **Inadequate Stability Program (21 CFR 211.166(a)):** Stability samples were not tested within stipulated timeframes, leading to delayed OOS result investigations for products like Triamcinolone Acetonide Cream and LOPROX. 3. **Failure to Follow Complaint Procedures (21 CFR 211.198(a)):** Over half of 2018/2019 complaints remained open beyond 30 days, with some open over 150 days. The quality unit failed to adequately review complaints