# FDA 483 - ARISTIDES MANIATIS, M.D. - March 02, 2021

Source: https://www.globalkeysolutions.net/records/483/aristides-maniatis-md/a4105a47-9bf4-42c0-975e-214107639071

> FDA 483 for ARISTIDES MANIATIS, M.D. on March 02, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ARISTIDES MANIATIS, M.D.
- Inspection Date: 2021-03-02
- Product Type: drugs
- Office Name: Denver District Office
- Summary: An FDA inspection of Aristides Maniatis MD, a clinical investigator in Centennial, CO, revealed significant deficiencies in clinical trial conduct. Observations included inadequate investigational drug disposition records, with numerous missing drug vials, and a failure to report adverse events as required by the study protocol. These issues indicate a lack of adherence to regulatory requirements for clinical investigations.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/aristides-maniatis-md/c32f3e05-aba6-445b-8b8a-b1de1a6745ed

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