Exela Pharma Sciences LLC – FDA Warning Letter, Jul 18, 2019

On April 8, 2021, the FDA issued a Warning Letter to Exela Pharma Sciences, LLC, following an inspection from June 10 to July 18, 2019, at their Lenoir, NC facilities. The company, registered as an outsourcing facility under FDCA section 503B, was found to be producing drug products that failed to meet the conditions for exemptions from certain FDCA provisions.

The primary violation identified was the facility's non-compliance with section 503B(b)(5) of the FDCA, which mandates adverse event reporting. The FDA found that Exela Pharma Sciences' documented procedures for adverse event reporting were inadequate, specifically noting they only covered "NDA/ANDA products" and lacked reference to the required Safety Reporting Portal (SRP) or Electronic Submission Gateway (ESG) for submissions. This deficiency means their compounded drug products are not eligible for exemptions from FDA approval requirements (section 505), adequate directions for use labeling (section 502(f)(1)), and Drug Supply Chain Security Act requirements (section 582).

Consequently, the compounded drugs are considered unapproved new drug products, violating sections 505(a) and 301(d) of the FDCA, and misbranded drug products under section 502(f)(1) and 301(a) due to inadequate directions for use for conditions