# FDA 483 - Steven David, M.D. - January 08, 2018

Source: https://www.globalkeysolutions.net/records/483/steven-david-md/468817df-2c5f-48f5-b2ce-ec445ee654fb

> FDA 483 for Steven David, M.D. on January 08, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Steven David, M.D.
- Inspection Date: 2018-01-08
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Steven David, M.D. in Wayne, NJ, a sponsor investigator, revealed significant deficiencies in the conduct of clinical investigations. The observations primarily concern failures to maintain adequate and accurate subject records and Institutional Review Board correspondences, report adverse events promptly to the FDA, and retain required study records for the specified duration. These issues indicate a serious lack of adherence to regulatory requirements for clinical trials.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/michael-serrano/44c9d307-9d78-4480-b1d0-36096c056642)
- [investigator](https://www.globalkeysolutions.net/people/nina-yang/8d080437-2e05-4b75-8c53-b818d761cf1f)

Company: https://www.globalkeysolutions.net/companies/steven-david-md/7ab4fd6d-3a02-41f4-b742-6e878e3df96d

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