# FDA 483 - Rowena Punzalan, M.D. - February 07, 2025

Source: https://www.keypedia.com/records/483/rowena-punzalan-md/fcf32cb1-58f8-4508-969c-8641e4f31dda

> FDA 483 for Rowena Punzalan, M.D. on February 07, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rowena Punzalan, M.D.
- Inspection Date: 2025-02-07
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: Rowena Punzalan, M.D., a clinical investigator in Milwaukee, WI, was cited for significant deficiencies in conducting clinical investigations. Observations included failures in adhering to investigational plans, maintaining accurate case histories, and promptly reporting serious adverse events, including a subject's death, to the sponsor and IRB. These issues indicate a lack of proper oversight and adherence to study protocols and regulatory requirements.

## Related Documents

- [483 - 2021-01-15](https://www.keypedia.com/records/483/rowena-punzalan-md/e75ab854-d995-4810-9538-2ff024831e43)

## Related Officers

- [Mildred J. Tures](https://www.keypedia.com/people/mildred-j-tures/c21df23d-580f-4cdc-94a1-194d981e41be)
- [investigator](https://www.keypedia.com/people/dina-a-tallman/e9bf2b98-6697-4d7c-9052-84339536acfd)

Company: https://www.keypedia.com/companies/rowena-punzalan-md/44554c9c-3025-4ef1-a531-63032a5013a3

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