FDA WARNING_LETTER - Annovex Pharma, Inc - September 06, 2024

On March 5, 2025, the FDA issued Warning Letter #698115 to Annovex Pharma, Inc., an outsourcing facility registered under section 503B of the FDCA. The letter followed an inspection from August 26 to September 6, 2024, which revealed serious deficiencies in drug production practices and failure to meet 503B conditions, putting patients at risk.

Violations included: - **Failure to meet 503B conditions:** Annovex Pharma failed to submit the June 2024 drug product report and did not submit adverse event reports according to 21 CFR 310.305 requirements, including inadequate procedures for defining, investigating, and reporting serious and unexpected adverse events. This renders their compounded drugs ineligible for exemptions from FDA approval, adequate directions for use labeling, and Drug Supply Chain Security Act requirements. - **Adulterated drug products:** Drug products were prepared under insanitary conditions, including media fills not performed under challenging conditions with uninvestigated positive growth, and inadequate smoke studies. This constitutes adulteration under section 501(a)(2)(A) of the FDCA. - **CGMP violations:** The facility failed to establish and follow procedures to prevent microbiological contamination (21 CFR 211.113(b)), thoroughly investigate discrepancies (21 CFR 211.19