FDA 483 - Microbiologics Inc - November 26, 2019

Microbiologics Inc, a manufacturer in Saint Cloud, MN, was cited for two observations during an FDA inspection. The firm failed to adequately document corrective and preventive actions related to false negative reports for their in vitro diagnostic products. Additionally, the labeling for an in vitro diagnostic product did not include a statement of known extrinsic factors affecting results, specifically regarding hydration buffer and volume.