FDA Issues Import Alert for Wockhardt FacilityBy
The US Food and Drug Administration (FDA) has issued an import alert for products manufactured from Wockhardt’s facility in Ankleshwar, India. The import alert is issued when a firm is not operating in conformity with current good manufacturing practices (GMPs). The alert was posted by the FDA on August 5, 2016.
The FDA has classified this alert as “detention without physical examination (DWPE) of drugs from firms which have not met drug GMPs.” The alert may be issued in several cases when foreign inspections of pharmaceutical manufacturers are being performed. DWPE may be appropriate when an FDA inspection has revealed that a firm is not operating in conformity with cGMPs. DWPE may also be appropriate when the FDA receives information concerning inspections conducted by foreign or other government authorities under a memorandum of understanding or other agreement that the FDA concludes reveals conditions or practices warranting detention of either particular products or all products manufactured by a firm.
The DWPE of such firms remains in effect until such time as the FDA is satisfied that the appearance of a violation has been removed, either by reinspection or submission of appropriate documentation to the responsible FDA center.