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

Source: https://www.globalkeysolutions.net/records/483/j-knipper-and-company-inc/ba4b28b0-8eb1-4807-8e6a-a1158c5cf913

> FDA 483 for J. Knipper and Company, Inc. on December 17, 2013. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: J. Knipper and Company, Inc.
- Inspection Date: 2013-12-17
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: 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.

## Related Officers

- [Liatte Krueger](https://www.globalkeysolutions.net/people/liatte-krueger/cbfda638-7610-43d9-9301-2e010665c86d)

Company: https://www.globalkeysolutions.net/companies/j-knipper-and-company-inc/561b6597-47fd-43c3-84ec-347fc8cb7da2

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248