# FDA 483 - Rowena Punzalan, M.D. - January 15, 2021

Source: https://www.keypedia.com/records/483/rowena-punzalan-md/e75ab854-d995-4810-9538-2ff024831e43

> FDA 483 for Rowena Punzalan, M.D. on January 15, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rowena Punzalan, M.D.
- Inspection Date: 2021-01-15
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: Dr. Rowena Punzalan, a Clinical Investigator in Milwaukee, was issued a Form FDA 483 following an inspection. The inspection revealed that the study site failed to report six protocol deviations to the IRB with the annual report, which was a requirement of the IRB standard operating procedures and the study protocol. This indicates a lapse in adherence to the investigational plan and reporting requirements.

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## Related Officers

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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