# FDA 483 - Kleen Test Products Corporation - June 14, 2006

Source: https://www.keypedia.com/records/483/kleen-test-products-corporation/3f8d02fe-2319-4b14-8da5-a860b8862173

> FDA 483 for Kleen Test Products Corporation on June 14, 2006. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kleen Test Products Corporation
- Inspection Date: 2006-06-14
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Kleen Test Products in Port Washington, WI, from June 8-14, 2006, revealed a significant quality control failure. The firm failed to thoroughly review an unexplained discrepancy where the wrong lot code for an active drug ingredient was listed in a batch record for an over-the-counter drug product. This indicates a lapse in their investigation and quality control processes.

## Related Documents

- [483 - 2022-03-25](https://www.keypedia.com/records/483/kleen-test-products-corporation/4160d5fa-6d4c-4544-be45-95affd0038e7)

## Related Officers

- [Janis R. Armendariz](https://www.keypedia.com/people/janis-r-armendariz/9d6e57f5-f0fc-49d8-bd2e-6e925976a08b)

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