# FDA 483 - Vinay Sikand, M.D. - September 14, 2023

Source: https://www.keypedia.com/records/483/vinay-sikand-md/ceda8bfd-61c1-4316-9631-8eb64362cc6d

> FDA 483 for Vinay Sikand, M.D. on September 14, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vinay Sikand, M.D.
- Inspection Date: 2023-09-14
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Vinay Sikand, M.D., a clinical investigator in Toms River, NJ, revealed significant deficiencies in the conduct of investigational drug studies. The firm was cited for inadequate record-keeping regarding investigational drug disposition and for failing to conduct investigations in accordance with approved plans. These issues indicate a lack of control over study materials and adherence to protocol requirements.

## Related Officers

- [investigator](https://www.keypedia.com/people/michael-serrano/44c9d307-9d78-4480-b1d0-36096c056642)
- [Mayar M. Mussa](https://www.keypedia.com/people/mayar-m-mussa/4f39b1c8-93a6-4bc9-a800-5f802db48be6)

Company: https://www.keypedia.com/companies/vinay-sikand-md/cc615f5c-4541-4813-a81d-92f4f29b316a

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