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

Source: https://www.keypedia.com/records/483/martin-e-gutierrez/4064a73f-e284-4340-8efa-f1a1660f9fd2

> 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: During an FDA inspection conducted from October 21 to November 20, 2024, clinical investigator Dr. Martin E. Gutierrez, associated with John Theurer Cancer Center, received a Form FDA 483 outlining two significant observations. These observations highlight concerns regarding the conduct and record-keeping of clinical investigations, falling under the regulatory framework that ensures the integrity and safety of human subject research.The primary issue identified was the failure to conduct an investigation according to the approved plan, specifically concerning the underreporting of adverse events. For instance, the inspection revealed that 21 adverse events were not reported across five subjects in one protocol, and four adverse events were omitted for one subject in another protocol. Such omissions are critical as they compromise patient safety oversight and the accuracy of study data.The second observation detailed a failure to maintain accurate case histories. An example cited was an adverse event log that incorrectly documented an infusion reaction on a day a subject did not receive any infusions, indicating discrepancies in patient records.Dr. Gutierrez is expected to provide a comprehensive response to the FDA, detailing corrective actions taken or planned to address these observations and ensure compliance with regulatory requirements for clinical trials. This response is crucial for demonstrating a commitment to patient safety and data reliability in ongoing and future research.

## Related Documents

- [483 - 2024-11-20](https://www.keypedia.com/records/483/martin-e-gutierrez/981ef80d-d92c-4d45-9b57-1aa0d73dab76)

## Related Officers

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

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

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