# FDA 483 - Berman, Gary D., MD, Clinical Investigator - March 29, 2021

Source: https://www.keypedia.com/records/483/berman-gary-d-md-clinical-investigator/2246473f-22ff-433c-9181-eb69b3731327

> FDA 483 for Berman, Gary D., MD, Clinical Investigator on March 29, 2021. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Berman, Gary D., MD, Clinical Investigator
- Inspection Date: 2021-03-29
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Berman, Gary D., MD, Clinical Investigator in Minneapolis, MN, revealed a significant issue regarding the conduct of investigations. The firm failed to adhere to the signed statement of investigator and investigational plan, specifically lacking an internal procedure for identifying, documenting, and resolving protocol deviations. This deficiency impacted the site's ability to manage eDiary entries and investigational product dose assignments.

## Related Officers

- [Investigator](https://www.keypedia.com/people/sharon-l-matson/1d2e6d91-1d00-455d-a2e6-a73b1c6b82cc)
- [investigator](https://www.keypedia.com/people/nicole-c-victoria/8c5f8060-452f-4fe5-a43f-a448ec020e60)

Company: https://www.keypedia.com/companies/berman-gary-d-md-clinical-investigator/f9a75410-4db9-4678-8734-3cf19058822d

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d