J. Knipper and Company, Inc.December 17, 2013

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

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Record Details

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.

Company: J. Knipper and Company, Inc.
Inspection Date: December 17, 2013
Product Type: Drugs
Office: New Jersey District Office
Person: Liatte Krueger

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ID · ba4b28b0-8eb1-4807-8e6a-a1158c5cf913