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

Source: https://www.keypedia.com/records/483/annovex-pharma-inc/b9967bd0-f719-40c0-8bed-78f04f70141d

> FDA 483 for Annovex Pharma, Inc. on September 06, 2024. Product: Cosmetics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Annovex Pharma, Inc.
- Inspection Date: 2024-09-06
- Product Type: Cosmetics
- Office Name: Baltimore District Office
- Summary: 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

## Related Officers

- [ Drug Investigator](https://www.keypedia.com/people/tekalign-wondimu/3b80e5c8-4062-4e1d-8ddd-b1afa2616dec)
- [Yaharn Su](https://www.keypedia.com/people/yaharn-su/75b7f7fd-d853-436e-b538-386a8c6df3cb)
- [Kara J. Wright](https://www.keypedia.com/people/kara-j-wright/d12b6a4f-9710-4811-b1b2-5ff5f9342155)

Company: https://www.keypedia.com/companies/annovex-pharma-inc/24fc76c5-e88a-4b2d-9d3b-9e6edf3779b0

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa