# FDA 483 - Adam J. Wolff, M.D. - December 05, 2023

Source: https://www.globalkeysolutions.net/records/483/adam-j-wolff-md/f47b485d-c437-48ba-be9e-5327fb6bacbc

> FDA 483 for Adam J. Wolff, M.D. on December 05, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Adam J. Wolff, M.D.
- Inspection Date: 2023-12-05
- Product Type: drugs
- Office Name: Denver District Office
- Summary: An FDA inspection of Adam Wolff, M.D. in Denver, CO, revealed significant deficiencies in the conduct of a clinical study. The firm failed to maintain adequate investigational drug disposition records, exhibiting numerous date and time discrepancies for investigational product preparation and administration. Additionally, the principal investigator did not adhere to the investigational plan, failed to maintain accurate source documents, and neglected to report a serious adverse event to the sponsor.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/courtney-r-bratina/3ad4bfd5-d0da-4801-8e90-a5a3ba9291c3)

Company: https://www.globalkeysolutions.net/companies/adam-j-wolff-md/8375dd1d-eb48-4565-bcd7-6f020f8d4aeb

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