FDA WARNING_LETTER - Panacea Biotec Pharma Limited - February 20, 2020

The FDA issued a Warning Letter to Panacea Biotec Limited following an inspection from February 10-20, 2020, at their facility in Tehsil Nalagarh, India. The letter identifies significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Inadequate Laboratory Controls (21 CFR 211.160(b))**: The firm failed to establish scientifically sound laboratory controls. Specifically, they lacked data on microorganism identification from aseptic processing, identifying only 1 out of 6360 isolates in 2019 from the ISO 7 area. They also used an incomplete photographic library for visual identification and failed to record basic microbial differentiation data like gram stain or spore-forming characteristics. Additionally, analysts failed to perform critical steps (vortexing, using calibrated timers) during endotoxin analysis, and the gel clot method lacked sufficient instructions. The firm's response was deemed inadequate for not committing to identifying all isolates to at least the genus level and for not providing a retrospective review of laboratory practices and analyst competencies.

2. **Inadequate Environmental Monitoring (21 CFR 211.42(c)(10)(iv))**: The firm lacked an adequate system for monitoring environmental conditions in aseptic processing areas.