# FDA 483 - JAC Custom Pouches, Inc. - February 01, 2023

Source: https://www.keypedia.com/records/483/jac-custom-pouches-inc/362976cd-c071-4d5d-9c7a-db090097ca13

> FDA 483 for JAC Custom Pouches, Inc. on February 01, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: JAC Custom Pouches, Inc.
- Inspection Date: 2023-02-01
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: JAC Custom Pouches, Inc. in Dowagiac, MI, was inspected and received a Form 483 with five observations. The inspection revealed significant deficiencies in the firm's quality system, particularly concerning corrective and preventive actions, control of nonconforming product, complaint investigations, training procedures, and device history records. These issues indicate a lack of robust quality management practices.

## Related Officers

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

Company: https://www.keypedia.com/companies/jac-custom-pouches-inc/be0f01e7-d554-42a6-bb86-c4c91c7b3f05

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