# FDA 483 - Enrico Bertini MD - May 05, 2025

Source: https://www.keypedia.com/records/483/enrico-bertini-md/0d15c22d-86ad-4f8b-a5d3-03221efefa72

> FDA 483 for Enrico Bertini MD on May 05, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Enrico Bertini MD
- Inspection Date: 2025-05-05
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Clinical Investigator Enrico Bertini in Rome, Italy, revealed a significant issue regarding the maintenance of adequate case histories. The inspection found that source records and case report forms for a study, including data related to mFARS, walking tests, pharmacy activities, and investigator oversight, were not accurate, attributable, legible, complete, or contemporaneous. This indicates a serious concern with data integrity and record-keeping practices in the clinical investigation.

## Related Officers

- [investigator](https://www.keypedia.com/people/gabrielle-j-swain/55f33430-41dc-4fae-bac0-ec6ea340feb6)

Company: https://www.keypedia.com/companies/enrico-bertini-md/9fe91be6-cee6-438b-b79d-0d800b29cb6c

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd