483
Dr. Vendel KemenyDr. Vendel Kemeny – FDA 483, May 26, 2026
Record Details
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.
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