# FDA 483 - Eugenia Girda, MD - October 18, 2022

Source: https://www.globalkeysolutions.net/records/483/eugenia-girda-md/945a56cc-b2ca-4e25-bd23-2e29869a6298

> FDA 483 for Eugenia Girda, MD on October 18, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eugenia Girda, MD
- Inspection Date: 2022-10-18
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Eugenia Girda, MD, a clinical investigator in New Brunswick, NJ, revealed a significant issue regarding the conduct of a clinical study. The investigator failed to report multiple adverse experiences for several subjects to the sponsor, which is a violation of the signed FDA 1572 Investigator Agreement. This indicates a serious lapse in adherence to clinical trial protocols and regulatory requirements.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/michael-serrano/44c9d307-9d78-4480-b1d0-36096c056642)

Company: https://www.globalkeysolutions.net/companies/eugenia-girda-md/8ef5c779-8b54-42f1-aa09-6171b31bd83a

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