Caraco enters into a consent decree with the FDA regarding its drug manufacturing operations

Sep 30 2009

Caraco Pharmaceutical Laboratories, Ltd. (NYSE Amex: CPD) announced today that it has entered into a consent decree with the U.S. Food and Drug Administration (FDA) 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 and to facilitate a successful result.

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.