The QMN Weekly Bulletin

Cooper Division Gets Closeout on Complaint Handling Warning Letter

Oct. 19, 2012
CooperSurgical subsidiary Norland got FDA closeout on a warning letter the company received for deviations in complaint handling and good manufacturing practices at its Fort Atkinson, Wis., plant. Norland also had not submitted device correction or removal reports to the FDA within 10 days, as is required, the letter states. One software fix was implemented in June 2011, but the FDA was not informed until Sept. 23, 2011, after the conclusion of the inspection.
Devices & Diagnostics Letter