FDA OKs Caraco's plan to rehab Detroit ops

Caraco is traveling the long road back to GMP compliance. Parent company Sun Pharma said last week that the subsidiary had won FDA approval for a work plan to restart production at its Michigan facilities, from which U.S. Marshals seized drug inventories last year on behalf of the FDA for repeated manufacturing violations.

Per a consent decree, the drugmaker suspended Detroit-area operations and laid off more than 400 employees. It can resume production only after independent experts and the FDA agree that facilities, equipment and processes are GMP compliant. Approval of the work plan, submitted in early 2010, is a first milestone in the comeback effort.

Caraco's manufacturing troubles extended beyond the FDA and U.S. Marshals to investors, who wasted little time following the drug seizures to file class-action suits. Investors charged that the company made false and misleading statements about its operations and failed to take corrective actions.

- here's the article
- see this WSJ report

Suggested Articles

The FDA has lambasted the Torrent Pharmaceuticals in a warning letter for making OTC meds using water tainted with bacteria.

Eli Lilly is investing $400 million in its Indianapolis site to expand production of insulin and other diabetes meds, and add 100 jobs.

Recipharm has been building its capabilities in sterile injectable and inhalation drugs. Now it is buying a CDMO that manufactures devices for both.