# FDA 483 - Northfelt, Donald MD - December 14, 2018

Source: https://www.globalkeysolutions.net/records/483/northfelt-donald-md/edced2af-7d64-4f61-81a5-8748efa008ae

> FDA 483 for Northfelt, Donald MD on December 14, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Northfelt, Donald MD
- Inspection Date: 2018-12-14
- Product Type: drugs
- Office Name: Denver District Office
- Summary: An FDA inspection of Donald W. Northfelt, MD, a clinical investigator in Phoenix, AZ, revealed that an investigation was not conducted in accordance with the investigational plan. Specifically, plasma samples for pharmacokinetic assessment were not collected for two subjects at specified timepoints, and related vital signs, labs, and concomitant medications were not completed or reported to the IRB.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/michelle-j-hines/c8087e41-6b8a-4b9a-92ad-bba500ce6fee)

Company: https://www.globalkeysolutions.net/companies/northfelt-donald-md/be63bb76-de6f-4ad4-9c62-8717f379eac7

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