# FDA 483 - Robert L. Tychsen, MD - March 11, 2022

Source: https://www.keypedia.com/records/483/robert-l-tychsen-md/422df7c8-f1ff-4378-a59c-2f99915d91fa

> FDA 483 for Robert L. Tychsen, MD on March 11, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Robert L. Tychsen, MD
- Inspection Date: 2022-03-11
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of Robert L. Tychsen, MD, a clinical investigator in St Louis, MO, revealed significant deficiencies in the protection of human subjects. Observations included failures to obtain informed consent prior to study procedures and discrepancies in the documentation of consent. Additionally, subject case history records were found to be inaccurate or incomplete, with issues regarding original consent forms and participant identification.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/karen-m-montgomery/ee91b1bb-8d51-4fdc-bee5-949441136e59)

Company: https://www.keypedia.com/companies/robert-l-tychsen-md/b20860fe-adae-48d6-8411-2ec435ec146b

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8