# FDA 483 - Rosa Maria Jimenez Rodriguez, M.D.,Ph.D. - December 20, 2024

Source: https://www.keypedia.com/records/483/rosa-maria-jimenez-rodriguez-mdphd/08ef2de1-cda3-4220-9b96-20eb7ab933dc

> FDA 483 for Rosa Maria Jimenez Rodriguez, M.D.,Ph.D. on December 20, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rosa Maria Jimenez Rodriguez, M.D.,Ph.D.
- Inspection Date: 2024-12-20
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Rosa Maria Jimenez Rodriguez, M.D.,Ph.D., a clinical investigator in Sevilla, Spain, revealed significant deficiencies in maintaining adequate case histories. The firm failed to document appropriate storage conditions for investigational product infusions, administered doses contrary to the IP manual, and incorrectly calculated a subject's screening score. These findings indicate serious issues with data integrity and adherence to study protocols.

## Related Officers

- [investigator](https://www.keypedia.com/people/tyanna-n-hadley/8fdebfd7-d6f3-44ab-9dcb-864ab6d55d53)

Company: https://www.keypedia.com/companies/rosa-maria-jimenez-rodriguez-mdphd/ee55c88a-1ebd-4e2e-a976-da9fe6270b1f

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8