FDA 483 - J. Knipper and Company, Inc. - December 17, 2013

MediMedia USA Co., a repackager/relabeler in Carlstadt, NJ, was inspected from December 10-17, 2013. The inspection revealed significant deficiencies in the firm's quality control unit, specifically regarding the written procedures and their adherence for handling customer inquiries, investigations, corrective/preventive actions, customer notifications, and change control. These issues indicate a lack of robust quality system oversight and documentation.