# FDA 483 - Neil Sheth, MD - November 24, 2020

Source: https://www.keypedia.com/records/483/neil-sheth-md/e9e647f3-bf0c-4ac3-942e-7fca344b80b8

> FDA 483 for Neil Sheth, MD on November 24, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Neil Sheth, MD
- Inspection Date: 2020-11-24
- Product Type: drugs
- Office Name: Denver District Office
- Summary: An FDA inspection of Neil Sheth, MD, a clinical investigator in Glendale, AZ, revealed significant deficiencies in clinical trial conduct. The firm failed to maintain adequate and accurate case histories, with discrepancies noted in subject dose entries and eDiary completion. Additionally, investigations were not conducted according to the investigational plan, leading to numerous missed subject visits and diary reviews.

## Related Officers

- [Julian C. Hanson](https://www.keypedia.com/people/julian-c-hanson/489e27d9-0de6-4bf0-8aec-e5d500841f52)
- [issuing_officer](https://www.keypedia.com/people/michelle-j-hines/c8087e41-6b8a-4b9a-92ad-bba500ce6fee)

Company: https://www.keypedia.com/companies/neil-sheth-md/e4bd4876-e6dc-4109-a089-c2ddab3b8508

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