FDA 483 - JC World Bell Co., Inc. - September 09, 2020

During an inspection from August 31 to September 9, 2020, JC World Bell Co., Inc. in Hackensack, NJ, an OTC secondary repacker/distributor, was cited for significant deficiencies in its quality control unit and batch production records. The firm failed to follow written procedures, distributed recalled products, and maintained incomplete batch records, indicating a lack of adequate controls over its drug product operations.