Biomet U.K. facility cited for design transfer deficiencies in FDA warning letter.
This article was originally published in The Gray Sheet
Executive Summary
BIOMET U.K. PLANT DESIGN TRANSFER DEFICIENCIES CITED BY FDA in a Nov. 1 warning letter to the Bridgen, U.K. facility. Stemming from a July 29-31 inspection, the two-page warning letter says that Biomet failed "to establish and implement specification control measures to assure that the design basis for the device and packaging is correctly translated into approved specifications." The citations relate to Biomet's production of Brooker-Wills orthopedic cancellous screws.