# FDA 483 - Kleen Test Products Corporation - March 25, 2022

Source: https://www.keypedia.com/records/483/kleen-test-products-corporation/4160d5fa-6d4c-4544-be45-95affd0038e7

> FDA 483 for Kleen Test Products Corporation on March 25, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kleen Test Products Corporation
- Inspection Date: 2022-03-25
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: Kleen Test Products Corporation, a medical device manufacturer in Port Washington, WI, was cited for inadequate process validation during an FDA inspection. The firm failed to perform a performance qualification for a checkweigher and used an inappropriate justification for not validating a medical device filling process. These deficiencies indicate significant issues with the firm's quality system regarding equipment and process validation.

## Related Documents

- [483 - 2006-06-14](https://www.keypedia.com/records/483/kleen-test-products-corporation/3f8d02fe-2319-4b14-8da5-a860b8862173)

## Related Officers

- [investigator](https://www.keypedia.com/people/nicholas-t-domer/8e2d2ff5-b0da-4b0d-bd65-492a49ae1035)

Company: https://www.keypedia.com/companies/kleen-test-products-corporation/5b76e51e-10c8-42da-8248-f0adde6746be

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