# FDA 483 - Kristen M. Pettit, M.D. - April 15, 2026

Source: https://www.keypedia.com/records/483/kristen-m-pettit-md/569aaed6-18a2-435f-918a-c2701b7b2a24

> FDA 483 for Kristen M. Pettit, M.D. on April 15, 2026. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Kristen M. Pettit, M.D.
- Inspection Date: 2026-04-15
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Kristen M. Pettit, M.D. in Ann Arbor, MI, revealed significant deficiencies in the conduct of a clinical investigation. Observations included failures to properly investigate product complaints, incorrect subject eligibility assessments, errors in randomization, and non-adherence to subject withdrawal criteria. Additionally, inaccurate concomitant medication data led to an erroneous classification of a subject's primary efficacy endpoint.

## Related Officers

- [investigator](https://www.keypedia.com/people/dina-a-tallman/e9bf2b98-6697-4d7c-9052-84339536acfd)

Company: https://www.keypedia.com/companies/kristen-m-pettit-md/5d5056c1-7b1c-4ee4-a79d-653ec2c872f8

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0