# Dr. Vendel Kemeny – FDA 483, May 26, 2026

Source: https://www.keypedia.com/records/483/dr-vendel-kemeny/88a4816e-d6eb-4565-8a24-474a42ca46b0

> FDA 483 for Dr. Vendel Kemeny on May 26, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dr. Vendel Kemeny
- Inspection Date: 2026-05-26
- Product Type: drugs
- Office Name: Division of Blood Components and Devices
- Summary: The FDA inspected Dr. Vendel Kemeny, a clinical bioequivalence facility in Budapest, Hungary, from May 26-29, 2026. The inspection revealed a significant deficiency in maintaining adequate and accurate case histories, specifically regarding the documentation of sample processing parameters for a study. This indicates a failure to properly record critical data during centrifugation, impacting the reliability of study records.

## Related Officers

- [Investigator](https://www.keypedia.com/people/lori-gioia/34b9339b-0bd2-4e41-8da1-b445ad829e53)

Company: https://www.keypedia.com/companies/dr-vendel-kemeny/5b78da19-b6dc-4aee-8c28-e5c40608a2a6

Office: https://www.keypedia.com/offices/division-of-blood-components-and-devices/02cc5ccf-d21e-445f-91e7-474736bc8917