# FDA 483 - Idalia Acosta, M.D. - January 16, 2025

Source: https://www.keypedia.com/records/483/idalia-acosta-md/548ad927-84a0-44e2-af6f-5add518194c6

> FDA 483 for Idalia Acosta, M.D. on January 16, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Idalia Acosta, M.D.
- Inspection Date: 2025-01-16
- Product Type: other
- Office Name: Florida District Office
- Summary: The FDA inspected San Marcus Research Clinic, Inc. in Miami Lakes, FL, as a clinical investigator, revealing significant deficiencies in maintaining adequate and accurate case histories. The inspection found multiple instances of data discrepancies, including conflicting screening weights, inconsistent investigational product accountability, and missing or duplicated source documentation for study subjects. These observations highlight serious concerns regarding the integrity and reliability of clinical trial data at the facility.

## Related Officers

- [investigator](https://www.keypedia.com/people/emily-a-baldwin/92d70174-7029-44f4-af30-e3230d4e9507)
- [Ricardo Vela](https://www.keypedia.com/people/ricardo-vela/b090df1e-9d71-423a-9ec8-efaaaff5dda3)

Company: https://www.keypedia.com/companies/idalia-acosta-md/1fe102a1-f4d9-454d-ba9a-5e08b0b3473f

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9