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

On July 2, 2025, the FDA issued a Warning Letter to Exela Pharma Sciences, FEI 3008563008, following an inspection from November 4-15, 2024, at their Lenoir, NC facility. The letter cited significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Inadequate Investigations (21 CFR 211.192):** The firm invalidated failing growth promotion results for media used in sterility testing of numerous drug products (e.g., ephedrine sulfate, potassium acetate) without adequate root cause investigation. Human error was cited without specific identification or corrective actions. Similarly, out-of-specification (OOS) results for sub-visible particulate matter in sodium bicarbonate injection were invalidated without sufficient investigation or recurrence prevention. 2. **Incomplete Laboratory Records (21 CFR 211.194(a)):** Microbiology testing results were inaccurately documented, and a second person did not verify test results for accuracy. An FDA investigator observed miscounted environmental monitoring plates.

The facility was also registered as an outsourcing facility under section 503B but deregistered on December 20, 2024, with intent to discontinue 5