# FDA 483 - Julio Wainstein - February 13, 2019

Source: https://www.keypedia.com/records/483/julio-wainstein/8c0a42a2-a864-4844-9ea3-0549a128a29f

> FDA 483 for Julio Wainstein on February 13, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Julio Wainstein
- Inspection Date: 2019-02-13
- Product Type: drugs
- Office Name: Center for Veterinary Medicine
- Summary: An FDA inspection of Julio Wainstein, a clinical investigator in Tel Aviv, Israel, revealed a significant failure to maintain adequate and accurate case histories. Specifically, numerous adverse events and concomitant medications for randomized subjects were not documented in source documents or final case report forms. This indicates a serious deficiency in data integrity and record-keeping practices.

## Related Officers

- [Julian C. Hanson](https://www.keypedia.com/people/julian-c-hanson/489e27d9-0de6-4bf0-8aec-e5d500841f52)
- [investigator](https://www.keypedia.com/people/tawny-l-colling/4ce51467-468c-4271-a98d-4b13c15c0812)

Company: https://www.keypedia.com/companies/julio-wainstein/936b9a01-ef78-436d-9dd8-82a69cd6cf32

Office: https://www.keypedia.com/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4