Annovex Pharma, Inc.

Warning LetterOpen

Adedayo Akinbi Founder and CEO Annovex Pharma, Inc. 7403 Lockport PI, Suite C-D Lorton , VA 22079 United StatesFEI 3020928491Issued Mar 5, 2025Center for Drug Evaluation and Research (CDER)

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3020928491.

Violations7

Issue DateMar 5, 2025

Product TypeDrugs

StatusOpen

Letter Details

Firm: Annovex Pharma, Inc.
Location: Adedayo Akinbi Founder and CEO Annovex Pharma, Inc. 7403 Lockport PI, Suite C-D Lorton , VA 22079 United States
FEI Number: 3020928491
Country: United States
Issue Date: March 05, 2025
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

Annovex Pharma, Inc., a registered outsourcing facility (compounding pharmacy), produced drug products that failed to meet the conditions required under section 503B of the Federal Food, Drug, and Cosmetic Act to qualify for exemptions from drug approval and labeling requirements. During an FDA inspection from August 26 to September 6, 2024, investigators identified serious deficiencies in the company's manufacturing practices that put patients at risk and determined that the compounded drugs violated the FDCA. The facility had registered as an outsourcing facility in October 2021 but failed to maintain the necessary compliance standards for this category.

Annovex Pharma, Inc. FDA Warning Letter, March 5, 2025