Exela Pharma Sciences, LLC
FDA issued a warning letter to Exela Pharma Sciences, LLC (Lenoir, NC) following a November 2024 inspection of its drug manufacturing and outsourcing facility, citing significant CGMP violations under 21 CFR parts 210 and 211. Key violations included inadequate investigation of out-of-specification and failing sterility/growth-promotion test results, inaccurate documentation of microbiology test results, and multiple deficiencies in sterility testing, stability programs, personnel training, and visual inspection programs for sterile compounded drug products. The facility had already deregistered as a 503B outsourcing facility in December 2024, but FDA warned that violations would apply if operations resume. FDA demanded written corrective actions within 15 working days and cautioned that failure to comply could result in seizure, injunction, withholding of export certificates, and denial of new drug application approvals.
Required actions (5)
After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence.
you should also notify us fifteen (15) working days prior to resuming production of drugs under section 503B of the FD&C Act in the future by contacting [email protected].
Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.
FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP.
We may re-inspect to verify that you have completed corrective actions to address any violations.
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