FDA 483 - JC World Bell Co., Inc. - November 19, 2024

An FDA inspection of JC World Bell Co., Inc., an OTC secondary repacker/distributor in Hackensack, NJ, revealed significant deficiencies in their quality control unit, production and process controls, and equipment calibration. The firm failed to validate packaging processes, perform routine weight verification for analytical balances, and ensure proper review of warehouse qualification documents by the Quality Unit. These issues indicate a lack of adequate controls to assure drug product quality and compliance.