For Caraco, it's all GMP now

Talk about a stressed-out PR department: Caraco (CPD [1]) announced yesterday that it has entered into a consent decree with the FDA concerning its shut-down manufacturing operations in Detroit. The announcement follows by less than a week a release detailing the resignation of a member of its board.

These announcements, of course, follow rapid-fire June and July releases concerning first the FDA's seizure of drugs and then the facility shut-downs, followed by the layoff of more than half its workforce.

The decree involves a punch-list of manufacturing operations items to bring the facilities and operations up to GMP par; once completed to the satisfaction of the FDA and outside experts, Caraco can resume production. The company says in an announcement that it is "working expeditiously to satisfy the requirements of the decree and has already retained independent cGMP experts."

The departed board member is Georges Ugeux, who cited in his resignation letter disagreements with management on corporate governance and the fiduciary role of directors. Caraco, however, said it believes the disagreements relate to the role of the independent directors in working with the FDA on the Detroit manufacturing fiasco.

- here's the consent decree announcement [2]
- see the Ugeux release [3]
- start here to see our earlier coverage [4]

Related Articles:
Keep those pills in shape [5]
Caraco finds lawyers in back of regulators [4]
FDA seizure intended to drive "major changes" at Caraco [6]