# FDA 483 - Dipakkumar P. Pandya, M.D. - February 01, 2024

Source: https://www.keypedia.com/records/483/dipakkumar-p-pandya-md/c13ee1be-222d-4b62-ad8f-f8aa2b49ca31

> FDA 483 for Dipakkumar P. Pandya, M.D. on February 01, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dipakkumar P. Pandya, M.D.
- Inspection Date: 2024-02-01
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Dipakkumar P. Pandya, M.D. in Annandale, NJ, revealed significant deviations from clinical study protocols and inadequate record-keeping. The firm failed to conduct required safety assessments, monitor investigational product storage, and maintain complete and correct informed consent forms and subject data. These issues indicate a lack of adherence to good clinical practice during the study.

## Related Officers

- [investigator](https://www.keypedia.com/people/michael-serrano/44c9d307-9d78-4480-b1d0-36096c056642)
- [Investigator](https://www.keypedia.com/people/jay-b-shah/c437fff9-807e-4dea-80c0-8f77850db6f8)

Company: https://www.keypedia.com/companies/dipakkumar-p-pandya-md/631c758f-82bc-4c31-af74-60c256273243

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