# FDA 483 - Vasyl Melnyk - September 14, 2021

Source: https://www.globalkeysolutions.net/records/483/vasyl-melnyk/8ec0304f-2b45-40b4-9b78-34835cd559b7

> FDA 483 for Vasyl Melnyk on September 14, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vasyl Melnyk
- Inspection Date: 2021-09-14
- Product Type: drugs
- Office Name: Center for Veterinary Medicine
- Summary: An FDA inspection of Vasyl Melnyk, a clinical investigator in Kyiv, Ukraine, revealed a significant issue with record retention. The firm failed to retain investigational records for a period of two years following the approval of a drug's marketing application. This included critical documents such as signed informed consent forms, medical history, and other study-related records for a Phase 2 clinical trial.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/tawny-l-colling/4ce51467-468c-4271-a98d-4b13c15c0812)

Company: https://www.globalkeysolutions.net/companies/vasyl-melnyk/34573cc0-35d9-46b0-892e-cc5339fbc028

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