# FDA 483 - Paradox Inc - October 11, 2024

Source: https://www.keypedia.com/records/483/paradox-inc/157d4ae1-9241-4537-a6b2-afe0a6527d84

> FDA 483 for Paradox Inc on October 11, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Paradox Inc
- Inspection Date: 2024-10-11
- Product Type: drugs
- Office Name: Kansas City District Office
- Summary: Paradox Inc, a contract laboratory in Saint Joseph, MO, was cited for significant deficiencies during an FDA inspection. Observations included failures in maintaining electronic data backups and audit trails, inadequate investigations into out-of-specification results and discrepancies, and a lack of adherence to quality control procedures and data integrity principles. Additionally, the facility exhibited poor maintenance, with samples stored improperly and water damage observed in the laboratory.

## Related Documents

- [EIR - 2021-08-04](https://www.keypedia.com/records/eir/paradox-inc/99d6e2fb-b353-4476-b5e3-7249bc4e0d57)
- [483 - 2021-08-04](https://www.keypedia.com/records/483/paradox-inc/f46b3f7c-3955-478c-9997-da3d06930084)

## Related Officers

- [Consumer Safety Officer, FDA](https://www.keypedia.com/people/conner-n-mann/626fec03-b389-435c-b038-376fcc0952ac)
- [Consumer Safety Officer](https://www.keypedia.com/people/eric-d-bowles/bb6c783b-0933-4231-b79e-c591cbc50104)

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

Office: https://www.keypedia.com/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79