Synthes gets a warning letter from FDA for poor complaint management

Synthes gets warning letter over complaint management (MedCityNews)
 
Swiss 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 ...