Devices & Diagnostics Letter

Oct. 15, 2012 | Vol. 39 No. 41

Cooper Division Gets Closeout on Complaint Handling Warning Letter

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.

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Inadequate GMPs Garner Warning Letter for Italian Devicemaker Devicemaker Surprised by Warning Letters, Had Responded to 483 Va. Kit Company Gets Closeout Letter on GMP Gaps, Unapproved Product FDA Issues 11-Count Warning Letter on GMP Documentation, Training

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