# FDA 483 - Paradox Inc - August 04, 2021

Source: https://www.keypedia.com/records/483/paradox-inc/f46b3f7c-3955-478c-9997-da3d06930084

> FDA 483 for Paradox Inc on August 04, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Paradox Inc
- Inspection Date: 2021-08-04
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Paradox Inc., D.B.A Custom Industrial Analysis Labs Inc, a contract testing laboratory in Saint Joseph, MO, was cited for significant deficiencies in its quality control and laboratory operations. The inspection revealed failures in method validation, discrepancy investigations, quality unit procedures, and computer system controls. These issues indicate a lack of robust quality systems necessary to ensure the reliability and integrity of testing results.

## Related Documents

- [EIR - 2021-08-04](https://www.keypedia.com/records/eir/paradox-inc/99d6e2fb-b353-4476-b5e3-7249bc4e0d57)
- [483 - 2024-10-11](https://www.keypedia.com/records/483/paradox-inc/157d4ae1-9241-4537-a6b2-afe0a6527d84)

## Related Officers

- [Wayne D. Mcgrath](https://www.keypedia.com/people/wayne-d-mcgrath/42db5ab0-2e0b-4909-951c-e7621cd04f6e)

Company: https://www.keypedia.com/companies/paradox-inc/14c91a8f-7d1f-4de2-a85f-7e7a04034113

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8