FDA 483 - Broder Bros., Co - September 20, 2019

Broder Bros., Co DBA Prime Line, a relabeler in Bridgeport, CT, was cited for significant deficiencies in its quality control, production, and facility management during an FDA inspection. Observations included failures to investigate product discrepancies, inadequate master and batch records, uncontrolled labeling operations, and a lack of written procedures and employee training for cGMPs. Additionally, the firm stored OTC drug products in an uncontrolled warehouse and failed to maintain clean and sanitary conditions.