Caraco Pharmaceutical Laboratories Enters Into Consent Decree With FDA

Caraco Pharmaceutical Laboratories has entered into a consent decree with the US Food and Drug Administration regarding the company’s drug manufacturing operations.

The decree provides a series of measures that, when satisfied, will permit Caraco to resume manufacturing and distributing those products that are manufactured in its Detroit area facilities. The company is working expeditiously to satisfy the requirements of the decree and has already retained independent cGMP experts for review of the company’s operations.

Under terms of the consent decree, Caraco’s cessation of manufacturing operations will continue until it receives written notification from independent experts and the FDA that it is in compliance with the decree and regulations and can resume operations. Nothing in the decree prohibits Caraco from distributing FDA approved drug products that are manufactured by third parties.

Detroit-based Caraco Pharmaceutical Laboratories, develops, manufactures, markets and distributes generic pharmaceuticals to the wholesalers, distributors, drugstore chains and managed care providers.