# FDA 483 - Janet Thomas, M.D. - November 27, 2017

Source: https://www.globalkeysolutions.net/records/483/janet-thomas-md/7d8d757e-fe02-4073-9745-8c1ff850c970

> FDA 483 for Janet Thomas, M.D. on November 27, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Janet Thomas, M.D.
- Inspection Date: 2017-11-27
- Product Type: drugs
- Office Name: Denver District Office
- Summary: Children's Hospital Colorado in Aurora, CO, was cited for significant deficiencies in its clinical investigations. Observations included failures to adhere to investigator statements regarding subject eligibility, dietary monitoring, and self-administration competency. Additionally, the firm failed to maintain adequate and accurate case histories, leading to unreported adverse events and inconsistent documentation. Informed consent documents also lacked descriptions of foreseeable risks related to required study supplements.

## Related Documents

- [483 - 2017-11-27](https://www.globalkeysolutions.net/records/483/janet-thomas-md/e14ba524-598f-4d84-a371-f1e7344924d3)

## Related Officers

- [Theressa B. Smith](https://www.globalkeysolutions.net/people/theressa-b-smith/80f0c339-7eac-4c73-b9f6-ecb368738fe6)

Company: https://www.globalkeysolutions.net/companies/janet-thomas-md/eb5e465a-faf1-4611-80b2-b97f991961e5

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