FDA threatens Synthes with fines and regulatory action over GMP problems

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 a...