# FDA 483 - Modavar Pharmaceuticals - November 15, 2024

Source: https://www.globalkeysolutions.net/records/483/modavar-pharmaceuticals/13b5b9d8-3b1b-4a65-b0aa-c2286d4278b8

> FDA 483 for Modavar Pharmaceuticals on November 15, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Modavar Pharmaceuticals
- Inspection Date: 2024-11-15
- Product Type: drugs
- Office Name: Baltimore District Office
- Summary: An FDA inspection of Modavar Pharmaceuticals, LLC in Frederick, MD, revealed a significant deviation from established protocols. The firm failed to implement blinding procedures for analysts during IVRT studies, as required by their own Blinding Protocol. This indicates a lapse in adherence to internal study conduct procedures.

## Related Documents

- [483 - 2023-01-27](https://www.globalkeysolutions.net/records/483/modavar-pharmaceuticals/c92137de-e20f-4742-8627-95ff3f61c438)

## Related Officers

- [Sylvestre K. Dossou](https://www.globalkeysolutions.net/people/sylvestre-k-dossou/962f9277-7643-4f66-add9-1c3553fa1c14)

Company: https://www.globalkeysolutions.net/companies/modavar-pharmaceuticals/9b63702d-7db4-4738-8b79-5f7fc9cd73d6

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