Cardinal Health 303 Inc, San Diego, and the FDA have signed an amended consent decree to correct violations of current Good Manufacturing Practice (cGMP) requirements in the company’s infusion pumps.
Under the terms of the amended consent decree, Cardinal 303 must comply with the cGMP requirements and Quality System (QS) regulations in the designing, manufacturing, processing, packing, repacking, labeling, holding, or distributing of its infusion pumps.
The decree also directs Cardinal 303 to retain an independent expert consultant to inspect of all of its infusion pump facilities and recall procedures, and to submit to the FDA a corrective action plan detailing how it will bring its pumps into compliance with the Federal Food, Drug, and Cosmetic Act.
The FDA cited the company in both 2006 and 2007 for failing to comply with QS regulations. The new decree covers all of the company’s infusion pumps, including the Alaris System (formerly the Medley) infusion pump, the Gemini infusion pump, and the Med System III infusion pump.
Additional information is available on the FDA’s Web site.