# FDA 483 - Patel, Vikas V. - December 17, 2019

Source: https://www.globalkeysolutions.net/records/483/patel-vikas-v/33192636-8577-456a-8c4c-f8ec3f948ea1

> FDA 483 for Patel, Vikas V. on December 17, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Patel, Vikas V.
- Inspection Date: 2019-12-17
- Product Type: other
- Office Name: Denver District Office
- Summary: An FDA inspection of Vikas V. Patel, MD, Principal Investigator, in Aurora, CO, revealed significant deficiencies in the conduct of a clinical investigation. The firm failed to adhere to the investigational plan and FDA regulations, including issues with subject screening, incomplete pre-operative assessments, unperformed study procedures, and delayed adverse event reporting. Additionally, problems were noted with informed consent processes, premature promotion of an investigational device, and widespread inaccuracies and incompleteness in subject records and study correspondence.

## Related Officers

- [Lavender M Huskey](https://www.globalkeysolutions.net/people/lavender-m-huskey/9ad3f3d7-4f25-492a-b10a-ede8289e4797)
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Company: https://www.globalkeysolutions.net/companies/patel-vikas-v/ef0f31f9-a734-4bfc-ad49-e438058c4980

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face