The Food and Drug Administration has shown in recent actions that hidden, substandard facilities continue to manufacture adulterated drugs available in the US, violations the agency is pressing Congress for authority for stronger ability to identify those facilities.
‘Shadow’ Factory Challenges Continue For US FDA
Agency wants more information about API suppliers as it winds up case against KV Tech for hidden use of Dr. Reddy’s plant and seeks to find disappearing manufacturer of contaminated OTC eye drops.