# FDA 483 - Angela D. Ritter, M.D. - August 17, 2023

Source: https://www.globalkeysolutions.net/records/483/angela-d-ritter-md/240e0804-44a6-4c93-ac4d-21e9cc33fef4

> FDA 483 for Angela D. Ritter, M.D. on August 17, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Angela D. Ritter, M.D.
- Inspection Date: 2023-08-17
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Angela D. Ritter, M.D. in Gainesville, GA, a sponsor-investigator, revealed significant deviations in the conduct of a clinical investigation. The firm failed to adhere to the investigational plan, did not obtain proper IRB approval for protocol changes and subsequent emergency uses of the investigational product, and lacked adequate informed consent. Additionally, the firm failed to submit required annual reports to the FDA.

## Related Documents

- [WARNING_LETTER - 2023-08-17](https://www.globalkeysolutions.net/records/warning_letter/angela-d-ritter-md/ebe74730-1f1b-4cd6-b1e9-362db0d46194)

## Related Officers

- [Matthew R. Coleman](https://www.globalkeysolutions.net/people/matthew-r-coleman/6fc13ec4-a609-4c3c-961f-16cba13a3a3a)
- [investigator](https://www.globalkeysolutions.net/people/ann-b-borromeo/ca03a531-043c-4195-b100-a8a0fc763159)

Company: https://www.globalkeysolutions.net/companies/angela-d-ritter-md/8b7db282-7127-4db5-841e-f61792ea8116

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7