Food & Drug Inspection Monitor

摘要

Human Drugs: DSM Pharmaceuticals, Greenville, NC; Forest Pharmaceuticals, St. Louis, MO; Mallinckrodt, Raleigh, NC; Oregon Freeze Dry, Albany, NY; Purdue Pharma, Stamford, CT; Medical Devices: Berkline Corporation, Livingston, TN; Lordex, Houston, TX;Inspection Log; Shelhigh agrees to consent order; halts device distribution until GMP flaws are addressed: Shelhigh, Union, N.J., agreed July 3 to stop distributing its implantable medical devices until the company addresses all concerns that FDA has with the firm's manufacturing processes involving sterility issues. The United States District Court of New Jersey entered the consent order of injunction agreed to by Shelhigh. The consent order forbids Shelhigh from distributing all devices until its manufacturing methods, controls and facilities are in compliance with GMPs.