FDA 483 - Halo Pharmaceutical, Inc. d/b/a Cambrex Whippany - December 20, 2019

Halo Pharmaceuticals (DBA Cambrex Whippany) in Whippany, NJ, a drug manufacturer, was inspected by the FDA. The inspection revealed significant issues with the firm's warehousing procedures for drug products, including a lack of established procedures and failure to properly track materials in their ERP system. Additionally, the quality control unit was found to be non-compliant with its own procedures for handling and closing investigations, leading to numerous overdue investigations.