FDA WARNING_LETTER - Exela Pharma Sciences LLC - November 15, 2024

On July 2, 2025, the FDA issued a Warning Letter to Exela Pharma Sciences, LLC, following an inspection from November 4-15, 2024, at their Lenoir, NC drug manufacturing facility. The letter cites significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR parts 210 and 211) for finished pharmaceuticals, rendering their drug products adulterated under the FD&C Act.

Key violations include: 1. **Inadequate Investigations (21 CFR 211.192):** The firm failed to thoroughly investigate unexplained discrepancies or failures. This includes invalidating failing growth promotion results for sterility testing media without adequate root cause analysis, impacting numerous drug products. Similarly, out-of-specification (OOS) results for sub-visible particulate matter in sodium bicarbonate injection were invalidated without proper investigation or corrective actions, despite identified human error. The firm's responses were deemed inadequate for lacking revised procedures, comprehensive reviews, and protocols for retrospective assessments. 2. **Incomplete Laboratory Records (21 CFR 211.194(a)):** The firm failed to accurately document microbiology testing results, and test results were not verified by a second person for accuracy. An FDA investigator observed miscounted environmental monitoring plates. The firm's response was inadequate as it did not address the misread counts or potential data integrity concerns from single-