Ricola AgFebruary 18, 2022

FDA 483 - Ricola Ag - February 18, 2022

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Record Details

Ricola Ag, a pharmaceutical manufacturer, was cited for failing to thoroughly review unexplained discrepancies and batch failures during an FDA inspection. Specifically, 32 investigations into metal contamination over two years lacked identified root causes and corrective actions. This indicates a significant lapse in their quality management system.

Company: Ricola Ag
Inspection Date: February 18, 2022
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
Person: Matthew B. Casale ( Investigator )

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ID · c26c2209-0422-451f-857b-4f385c4a0d97