FDA 483 - Annovex Pharma, Inc. - September 06, 2024

An FDA inspection of Annovex Pharma, Inc., an outsourcing facility located at 7403 Lockport Pl Ste C-D, Lorton, VA, was conducted from August 26, 2024, to September 6, 2024. The inspection, led by Investigators Tekalign Wondimu, Kara J Wright, and Yaharn Su, identified seven observations regarding the firm's compliance with regulations for sterile drug products.

Key observations include:

1. **Inadequate Aseptic Process Validation:** The media fill program lacked sufficient validation. Specifically, not all integral units were incubated during media fills (e.g., only 4 out of 100 syringes from a 07/29/2024 media fill were incubated without scientific justification). Additionally, purchased media powder was not growth-promoted or suitability-tested prior to use, as evidenced by a 01/10/2024 Aseptic Process Simulation where in-house prepared media was not inoculated with USP-recommended microorganisms.

2. **Failure to Thoroughly Review Discrepancies:** The firm failed to investigate unexplained discrepancies or batch failures. For instance, 100 syringes showed microbial growth in a 01/04/2024 media fill, but the quality unit discarded them without scientific justification. No attempt was made to identify the organisms or assess the impact on distributed