SPOTLIGHT: FDA forces contract manufacturer to reform

Contract manufacturer Scientific Laboratories is in a world of hurt today, as FDA has barred it from manufacturing or distributing drug products until it brings its operations up to par. The company, which makes various prescription cough-and-cold meds, didn't ask FDA for approval for some of its drugs--a dozen of them--and didn't comply with required manufacturing protocols. The consent decree Scientific Labs signed requires it to get the FDA's blessing for any product it sells and to conform to good manufacturing practices. The drugs it's already made all have to be destroyed. And the agreement comes with a big or-else: If Scientific Labs doesn't comply, FDA can shut it down completely. Story | Item

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