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Poor Supplier Control Causing Recalls, FDA Says; Contract Is Key To Success

This article was originally published in The Silver Sheet

Executive Summary

SUPPLIER CONTROL PROBLEMS ARE ON THE RISE and may be contributing to an increase in medical device recalls, says FDA Quality Systems Expert Kim Trautman. "When the recalls come in and [firms are] identifying some of the causes for the recall, it seems to be more prevalent within the past five or so years that they are supplier issues," she notes. To combat the trend, FDA has begun emphasizing to industry the importance of complying with purchasing controls, as well as ensuring that supplier contracts adequately outline product and service requirements. "Sometimes the contracts and the expectations between the finished device manufacturer and the supplier are just too loose," Trautman says. Meanwhile, the agency admits it is having a tough time keeping up with "virtual manufacturing" and "internal supplying" arrangements...





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