FDA 483 - Madcar A Division of Century Direct Solutions - December 20, 2023

Madcar A Division of Century Direct Solutions, a human drug repackager in Islandia, NY, was cited for multiple significant deficiencies during an FDA inspection. Observations included a lack of strict control over labeling operations, improper storage conditions for drug products, and failures in determining actual/theoretical yields. Additionally, the firm failed to record deviations from procedures and maintained deficient batch records.