Exela Pharma Sciences LLC
FDA issued a warning letter to Exela Pharma Sciences LLC, a registered 503B outsourcing facility in Lenoir, NC, after a 2019 inspection found that its compounded drug products failed to meet the conditions of section 503B of the FDCA — specifically due to inadequate adverse event reporting procedures that did not reference the required Safety Reporting Portal or Electronic Submission Gateway. Because the 503B conditions were not met, the compounded drugs were deemed unapproved new drugs and misbranded products subject to full FDCA requirements. FDA demanded a written corrective action response within 15 working days and warned that failure to comply could result in seizure and injunction.
Flagged claims (3)
their labeling fails to bear adequate directions for their intended uses causing them to be misbranded under section 502(f)(1) of the FDCA
You do not have any FDA-approved applications on file for drug products that you compound.
your documented procedures only covered "NDA/ANDA products" and makes no reference to the required adverse event submission process utilizing the Safety Reporting Portal (SRP) or Electronic Submission Gateway (ESG)
Required actions (2)
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address the issues identified.
Failure to promptly correct these violations may result in legal action, including, without limitation, seizure and injunction.
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