# FDA 483 - Aukstuolis, Jim G., MD - February 01, 2019

Source: https://www.globalkeysolutions.net/records/483/aukstuolis-jim-g-md/917afc89-d46e-48a9-8364-065aa1d5a260

> FDA 483 for Aukstuolis, Jim G., MD on February 01, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aukstuolis, Jim G., MD
- Inspection Date: 2019-02-01
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: An FDA inspection of Dr. Jim G. Aukstuolis, MD, a clinical investigator in Little Rock, AR, revealed significant deficiencies in the conduct of a clinical investigation. The firm failed to adhere to the investigational plan, specifically regarding the reporting of adverse events, proper handling of genetic samples, and IRB reporting. Additionally, critical investigational records, including source documentation for subject vitals, were not retained for the required period.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/camille-d-brown/419869d2-1810-40ea-8e8a-687de7013f6a)
- [Bioresearch Monitoring Specialis](https://www.globalkeysolutions.net/people/denise-l-burosh/075a442f-67e0-4a65-9c09-e8819a329773)

Company: https://www.globalkeysolutions.net/companies/aukstuolis-jim-g-md/fb91bc0d-e8b2-4c2f-92f9-fb98ce797541

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9