FDA 483 - Microgenics Corporation - December 15, 2016

Microgenics Corporation, a manufacturer in Fremont, CA, was inspected by the FDA, resulting in one observation. The firm failed to adequately document corrective and preventive action activities, specifically closing a CAPA without fully investigating the root cause of nonconformities in their DRI Salicylate Serum Tox Assay. This indicates a deficiency in their quality system regarding CAPA procedures.