# FDA 483 - Kent C. Shih, MD, PI - November 15, 2016

Source: https://www.globalkeysolutions.net/records/483/kent-c-shih-md-pi/b32a2af9-4cbe-40a7-8924-8ffb16a0ab8a

> FDA 483 for Kent C. Shih, MD, PI on November 15, 2016. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Kent C. Shih, MD, PI
- Inspection Date: 2016-11-15
- Product Type: drugs
- Office Name: New Orleans District Office
- Summary: An FDA inspection of Kent C. Shih, MD, PI, a clinical investigator in Nashville, TN, revealed significant deviations from the investigational plan. The investigator failed to ensure subjects received protocol-required premedication within the specified timeframe and did not report all adverse events as mandated by the protocol. These findings indicate a failure to adhere to clinical trial protocols.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/laura-l-staples/fe59bc9c-b439-4dd8-8c8a-5fac6f7733f8)

Company: https://www.globalkeysolutions.net/companies/kent-c-shih-md-pi/9683bbb7-50bf-4bc9-ac8e-e57a4abc68e4

Office: https://www.globalkeysolutions.net/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea