FDA 483 - Halo Pharmaceutical, Inc. d/b/a Cambrex Whippany - February 17, 2023

An FDA inspection of Halo Pharmaceutical, Inc. d/b/a Cambrex in Whippany, NJ, from February 7-17, 2023, identified a significant issue with equipment qualification. The firm was cited for using production equipment in commercial manufacturing that was not appropriately qualified for its intended use. This indicates a critical lapse in ensuring manufacturing equipment meets regulatory standards.