# FDA 483 - Shlomo Pascal, M.D. - July 06, 2021

Source: https://www.keypedia.com/records/483/shlomo-pascal-md/14badc5e-cd65-4850-8a16-550ddf539906

> FDA 483 for Shlomo Pascal, M.D. on July 06, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shlomo Pascal, M.D.
- Inspection Date: 2021-07-06
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Shlomo Pascal, M.D. in Miami, FL, was issued a Form 483 with two observations following an FDA inspection. The firm failed to maintain adequate and accurate case histories, including the destruction of original paper source records for clinical trial subjects. Additionally, the investigation was not conducted in accordance with the investigational plan, with failures in completing study procedures and ensuring subject safety through proper re-consent.

## Related Officers

- [investigator](https://www.keypedia.com/people/emily-a-green/99d6d052-ed5c-4d09-9fad-f0d2b740725f)

Company: https://www.keypedia.com/companies/shlomo-pascal-md/2527a367-e1bb-4386-acec-c08f411a3aa3

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6