# FDA 483 - Martin E. Gutierrez - November 20, 2024

Source: https://www.globalkeysolutions.net/records/483/martin-e-gutierrez/981ef80d-d92c-4d45-9b57-1aa0d73dab76

> FDA 483 for Martin E. Gutierrez on November 20, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Martin E. Gutierrez
- Inspection Date: 2024-11-20
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Martin E. Gutierrez, a clinical investigator in Hackensack, NJ, revealed significant issues with the conduct of investigations and the accuracy of subject records. The firm failed to report numerous adverse events in accordance with investigational plans and did not maintain accurate case histories, including incorrect adverse event entries. These findings indicate serious deficiencies in clinical trial oversight and data integrity.

## Related Officers

- [Mayar M. Mussa](https://www.globalkeysolutions.net/people/mayar-m-mussa/4f39b1c8-93a6-4bc9-a800-5f802db48be6)

Company: https://www.globalkeysolutions.net/companies/martin-e-gutierrez/6f937dbe-1efd-46fb-88dc-9728e588847e

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