The US Food and Drug Administration (FDA) ordered the seizure, alleging that there had been “continued failure” from Caraco to comply with current good manufacturing practices (cGMP).
Caraco believes “that corrective actions have been made and continual improvements are in process” but the agency’s last inspection of the Detroit facility, which was completed in May, alleged “unresolved violations of cGMP”.
The seizure only affects Caraco’s Michigan facilities in Detroit, Farmington Hills, and Wixom.
Caraco has had issues with the FDA for 12 months, with voluntary recalls of oversized tablets being followed by a warning letter and now the seizure.
By launching “swift, aggressive enforcement” actions the FDA believes it can encourage companies to “agree to a wide range of changes and improvements to their drug manufacturing practices”.
Caraco has stated that it will work with the FDA to resolve the issues “as effectively and expeditiously as possible”.
The FDA believes that 33 drugs may be affected by the action but the presence of other manufacturers means that choline magnesium trisalicylate oral tablets are the only product that may be in short supply.
Sun revising guidance
Caraco is currently unsure how the seizure will affect its finances but Sun Pharma, its parent company, has withdrawn its guidance and will issue a revised outlook that factors in the FDA’s action.
Sun is considering transferring production to other facilities but acknowledged that this is a complex process and will need approval from the FDA. Following news of the seizure Sun’s share price fell by as much as 19 per cent.