# FDA 483 - Peter Karachunski, M.D. - January 16, 2025

Source: https://www.keypedia.com/records/483/peter-karachunski-md/fd1262a7-400e-430e-a11b-504071d0c331

> FDA 483 for Peter Karachunski, M.D. on January 16, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Peter Karachunski, M.D.
- Inspection Date: 2025-01-16
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: This FDA Form 483 was issued to Peter I. Karachunski, M.D., a clinical investigator in Minneapolis, MN, following an inspection from January 6-16, 2025. The inspection revealed a significant deficiency in maintaining adequate and accurate case histories, specifically concerning the documentation of adverse events in electronic case report forms (eCRFs) as required by protocol. This indicates a failure to ensure complete and accurate data recording in clinical investigations.

## Related Officers

- [Mildred J. Tures](https://www.keypedia.com/people/mildred-j-tures/c21df23d-580f-4cdc-94a1-194d981e41be)

Company: https://www.keypedia.com/companies/peter-karachunski-md/1a8973f9-8fd0-44da-b9b5-6c3c9d9292ad

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d