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

Source: https://www.keypedia.com/records/483/neil-sheth-md/96d97285-a901-437a-8d22-4b8a1bcf0784

> 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: FDA District Office — Denver, Colorado
- Summary: An FDA inspection of Neil Sheth, MD, a clinical investigator in Glendale, AZ, revealed significant deficiencies in maintaining accurate case histories and adhering to the investigational plan. The firm failed to ensure subjects completed required study entries, with discrepancies noted between actual completion and documented records. Additionally, a substantial number of subject records showed missed visits and diary reviews mandated by the study protocol.

## Related Documents

- [483 - 2020-11-24](https://www.keypedia.com/records/483/neil-sheth-md/e9e647f3-bf0c-4ac3-942e-7fca344b80b8)

## Related Officers

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

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

Office: https://www.keypedia.com/offices/fda-district-office-denver-colorado/1670d160-cbfd-48fd-b9c1-fbba4631fcb0