# FDA 483 - Modavar Pharmaceuticals - January 27, 2023

Source: https://www.globalkeysolutions.net/records/483/modavar-pharmaceuticals/c92137de-e20f-4742-8627-95ff3f61c438

> FDA 483 for Modavar Pharmaceuticals on January 27, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Modavar Pharmaceuticals
- Inspection Date: 2023-01-27
- Product Type: drugs
- Office Name: Office of Regulatory Affairs
- Summary: Modavar Pharmaceuticals, LLC, a non-sterile drug manufacturer in Frederick, MD, received an FDA Form 483 with eight observations following an inspection from January 18-27, 2023. The inspection revealed significant deficiencies in equipment qualification and maintenance, component testing, production controls, stability programs, and data integrity for computerized systems. These issues indicate a lack of adequate controls to ensure drug product quality and compliance with GMP regulations.

## Related Documents

- [483 - 2024-11-15](https://www.globalkeysolutions.net/records/483/modavar-pharmaceuticals/13b5b9d8-3b1b-4a65-b0aa-c2286d4278b8)

## Related Officers

- [Kathleen M. Jordan](https://www.globalkeysolutions.net/people/kathleen-m-jordan/e08b786a-47bf-4e78-ae96-9d94cdc20bdb)
- [Investigator](https://www.globalkeysolutions.net/people/amy-n-chen/c3515e0e-dbb9-4540-bd2b-82c06d00dd42)
- [Jazmine N. Brown](https://www.globalkeysolutions.net/people/jazmine-n-brown/194fc53f-942f-4e8c-a475-b7eac11be103)

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

Office: https://www.globalkeysolutions.net/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64