# FDA 483 - Nina Gentile M.D - May 27, 2022

Source: https://www.keypedia.com/records/483/nina-gentile-md/1beb7417-9745-45c1-aeb6-7934d5ab0c78

> FDA 483 for Nina Gentile M.D on May 27, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nina Gentile M.D
- Inspection Date: 2022-05-27
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Nina Gentile M.D. in Philadelphia, a clinical investigator, revealed a significant issue regarding the timely reporting of serious adverse events (SAEs). The firm failed to conduct investigations in accordance with the investigational plan, specifically by not reporting two subjects' SAEs within the required timeframe as stipulated by the study protocol. This indicates a lapse in adherence to clinical trial protocols and patient safety reporting.

## Related Officers

- [investigator](https://www.keypedia.com/people/stephanie-c-mangigian/0cf25e6b-1e5d-4088-a13c-11483e2380ba)

Company: https://www.keypedia.com/companies/nina-gentile-md/eeb58ffc-dce4-4cbb-a7a8-60355e2d4848

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8