FDA threatens fines, regulatory action over Synthes' GMP problems (Fierce Pharma Manufacturing)
The international medical device company Synthes has been producing rods, power tools and screws for orthopedics for years. But now the FDA is putting the screws to Synthes.
Finding complaint handling and production standards sorely inadequate at Synthes' West Chester, PA, plant, the FDA has issued a no-nonsense warning letter to the medical devicemaker, threatening it with "regulatory action" if it does not promptly fix the problems.
The FDA gave Synthes 6 months to address the issues, produce an audit by an outside expert that they are being resolved, and provide certification from the CEO that the action plan has been reviewed and is being implemented. Failure to do so could result in regulatory actions including "seizure, injunction, and/or civil money penalties."
Additionally, the FDA said premarket approvals for some of the company's medical devices could be withheld, and "Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected."
The severity of the threats is perhaps not surprising given that Synt...
