# FDA 483 - ChemRite CoPac, Inc. - February 21, 2013

Source: https://www.keypedia.com/records/483/chemrite-copac-inc/460847cd-5674-4d44-b422-519b5d108ca8

> FDA 483 for ChemRite CoPac, Inc. on February 21, 2013. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ChemRite CoPac, Inc.
- Inspection Date: 2013-02-21
- Product Type: other
- Office Name: Minneapolis District Office
- Summary: ChemRite CoPac, Inc. in Lannon, WI, received a Form FDA 483 following an inspection of its OTC, medical device, and cosmetic manufacturing operations. The inspection revealed significant deficiencies across quality control, including inadequate control of non-conforming products, unestablished CAPA procedures, lack of MDR procedures, and failures in microbial testing and equipment maintenance. These issues indicate a systemic breakdown in quality management and compliance with regulatory requirements.

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## Related Officers

- [Sandra A. Hughes](https://www.keypedia.com/people/sandra-a-hughes/ee1b9542-fe28-4618-a666-67a1ff736481)

Company: https://www.keypedia.com/companies/chemrite-copac-inc/a81a399e-073f-4c5d-a41f-19bc9d0c0bc3

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d