FDA 483 - Halo Pharmaceutical, Inc. d/b/a Cambrex Whippany - March 20, 2017

An FDA inspection of Halo Pharmaceutical, Inc. in Whippany, NJ, a drug manufacturer, revealed significant deficiencies across multiple areas of its operations. The firm lacked adequate written procedures for production controls, equipment cleaning, and reprocessing, and failed to thoroughly investigate out-of-specification results. Additionally, the facility's buildings were not maintained in a good state of repair, and raw materials were not stored to prevent contamination.