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.