# FDA 483 - Jatex, Inc. - June 15, 2023

Source: https://www.keypedia.com/records/483/jatex-inc/ed638f0c-4fd6-4d5d-aec3-0d14af18d2cd

> FDA 483 for Jatex, Inc. on June 15, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jatex, Inc.
- Inspection Date: 2023-06-15
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Jatex, Inc. in Nappanee, IN, revealed two significant observations regarding their quality system. The firm failed to adequately establish procedures for handling complaints, including investigation necessity and documentation, and did not properly establish process controls for a validated manufacturing process, leading to deviations from manufacturer specifications.

## Related Officers

- [ Investigator ](https://www.keypedia.com/people/suyang-qin/c32419c5-1b78-4014-9f94-cb7ab17dfe05)

Company: https://www.keypedia.com/companies/jatex-inc/caeeba3c-f522-4d45-a766-4d53ac49e473

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0