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Synthes gets warning letter over complaint management

9:21 am by | 0 Comments

FDA warning letterSwiss medical device manufacturer Synthes has received a warning letter from U.S. regulators taking issue with the company’s management of complaints over its devices and problems with orthopedic surgery devices.

It said a review of its factory in West Chester, Pennsylvania between June and September 2011 revealed that some complaints “were not promptly reviewed, evaluated, or investigated by a designated individual,” according to the letter.

The U.S. Food and Drug Administration said in the letter, dated Feb. 16, that the company would be required to hire a consultant to do an audit of the company’s factory and quality assurance and set a due date for that report for Aug. 10. If it does not comply, the letter said Synthes could face regulatory action.

The warning letter is the latest regulatory action against the company since four executives from its subsidiary Norian were sentenced to jail and fined over using a bone cement the FDA had not approved in a clinical trial, which led to the deaths of three people in surgery for vertebral compression fractures.

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Johnson & Johnson (NYSE:JNJ) acquired the company for $21.3 billion last year. As J&J reviews its own manufacturing issues at its problematic McNeil consumer division and with subsidiary DePuy Orthopedics facilities under the new leadership of incoming CEO Alex Gorsky, it could be an opportunity to improve good manufacturing practices across the board. Gorsky’s background might make him well suited to implementing changes to bring Synthes in line given his responsibility for the medical devices and diagnostics group, global supply chain, healthcare compliance and privacy and government affairs and policy as vice chairman to the executive committee.

 

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Stephanie Baum

By Stephanie Baum

Stephanie Baum is the East Coast Innovation Reporter for MedCityNews.com. She enjoys covering healthcare startups across health IT, drug development and medical devices and innovations deployed to improve medical care. She graduated from Franklin & Marshall College in Pennsylvania and has worked across radio, print and video. She's written for The Christian Science Monitor, Dow Jones & Co. and United Business Media.
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