# FDA 483 - Ponce Medical School Foundation, Inc. IRB - February 24, 2023

Source: https://www.keypedia.com/records/483/ponce-medical-school-foundation-inc-irb/3b362e39-5026-47dc-b9d0-7106cba48e03

> FDA 483 for Ponce Medical School Foundation, Inc. IRB on February 24, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ponce Medical School Foundation, Inc. IRB
- Inspection Date: 2023-02-24
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: The FDA issued a Form 483 to Ponce Medical School Foundation, Inc. in Ponce, PR, following an inspection of its Institutional Review Board. The inspection revealed significant deficiencies in IRB record-keeping, including inadequate meeting minutes, improperly maintained member lists, and a lack of written procedures for reporting unanticipated problems and notifying the institution of research decisions. These issues indicate a failure to ensure proper oversight and documentation of human subject research.

## Related Officers

- [investigator](https://www.keypedia.com/people/ana-p-barido/4af1fa64-245e-4470-bd4b-975681d10a77)

Company: https://www.keypedia.com/companies/ponce-medical-school-foundation-inc-irb/ff348dab-a9ac-4e44-be2b-e247c1ae6b57

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-iv/a8c8fd15-4e7a-46cb-903a-9980f7ea89e6