# FDA 483 - Joseph J.T. Sacco, MD - May 16, 2025

Source: https://www.keypedia.com/records/483/joseph-jt-sacco-md/bc29ec7b-e97b-464a-81ec-97bc48e2807e

> FDA 483 for Joseph J.T. Sacco, MD on May 16, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Joseph J.T. Sacco, MD
- Inspection Date: 2025-05-16
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Joseph J.T. Sacco, MD, a clinical investigator in Birkenhead, United Kingdom, identified a significant issue with data integrity. The firm failed to prepare or maintain adequate and accurate case histories, specifically by not reporting critical data into the electronic data capture (EDC) system. This omission resulted in incorrect information within the study's electronic case report forms (eCRF).

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/kathryn-l-suttling/2d4695ca-5ec3-4658-8f46-101cec4ca41d)
- [Kathryn Suttling](https://www.keypedia.com/people/kathryn-suttling/40a22409-8aba-4e9f-826b-0af51c1a7c0b)

Company: https://www.keypedia.com/companies/joseph-jt-sacco-md/8550f27b-e23d-4e13-aada-142551734b7f

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