FDA Warning Letter to Exela Pharma Sciences: Key Findings

During an inspection from November 4–15, 2024, at Exela’s Lenoir, NC site, the FDA identified multiple serious CGMP violations under 21 CFR 210/211. Several injectable drugs were deemed “adulterated” under section 501(a)(2)(B) of the FD&C Act. The company’s response to the FDA 483 issued on December 9, 2024, was considered inadequate, resulting in a Warning Letter.

Key deficiencies included:

• Manufacturing lapses: inadequate investigations of sterility test media failures, improper handling of out-of-specification (OOS) particle results, and insufficient corrective actions.
• Microbiology issues: incomplete lab records, inaccurate colony counts, compromised data integrity, and weak QA oversight.
• 503B facility violations: absence of batch sterility testing, unclear SOPs for growth promotion tests, and inadequate environmental monitoring controls.
• Other shortcomings: lack of process control documentation, insufficient training, poor visual inspection practices, and no robust stability program.

The FDA urged Exela to undertake a comprehensive systems review, strengthen microbiological and aseptic controls, and engage external sterile manufacturing experts before resuming operations.

25-08-2025