# Prof. Mariusz Kruk, M.D. Ph.D. – FDA 483, Sep 13, 2019

Source: https://www.keypedia.com/records/483/prof-mariusz-kruk-md-phd/71d5fb89-c75f-46d7-988b-93a5362b2a56

> FDA 483 for Prof. Mariusz Kruk, M.D. Ph.D. on September 13, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Prof. Mariusz Kruk, M.D. Ph.D.
- Inspection Date: 2019-09-13
- Product Type: drugs
- Office Name: Center for Veterinary Medicine
- Summary: Prof. Mariusz Kruk, M.D. Ph.D., a clinical investigator in Warsaw, Poland, received a Form 483 for significant deficiencies observed during an FDA inspection. The findings primarily concern inadequate record-keeping for case histories and poor accountability for investigational drug disposition. These issues highlight serious concerns regarding data integrity and control over study materials.

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Company: https://www.keypedia.com/companies/prof-mariusz-kruk-md-phd/e058c596-5eae-441f-8545-62d85a8af073

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