# FDA 483 - Deborah A. Goss, M.D. - March 17, 2025

Source: https://www.globalkeysolutions.net/records/483/deborah-a-goss-md/8d4466c5-aef8-474d-8617-05ea6c0f2a61

> FDA 483 for Deborah A. Goss, M.D. on March 17, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Deborah A. Goss, M.D.
- Inspection Date: 2025-03-17
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Deborah A. Goss, M.D. in Hackensack, NJ, revealed significant issues in the conduct and documentation of clinical investigations. The firm failed to adhere to its investigational plan, maintain complete records, and ensure the accuracy of subject case histories. Additionally, adverse device effects were not fully recorded or reported to the sponsor, indicating a lack of compliance with regulatory requirements for clinical trials.

## Related Officers

- [Mayar M. Mussa](https://www.globalkeysolutions.net/people/mayar-m-mussa/4f39b1c8-93a6-4bc9-a800-5f802db48be6)
- [investigator](https://www.globalkeysolutions.net/people/michael-serrano/44c9d307-9d78-4480-b1d0-36096c056642)

Company: https://www.globalkeysolutions.net/companies/deborah-a-goss-md/98e94411-18b5-44e0-a5ca-ffacfc3c8f79

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248
