# FDA 483 - Hatch Product Development LLC - December 11, 2025

Source: https://www.keypedia.com/records/483/hatch-product-development-llc/e48fc4f6-9e6d-4b61-8aaf-a301b28a039b

> FDA 483 for Hatch Product Development LLC on December 11, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hatch Product Development LLC
- Inspection Date: 2025-12-11
- Product Type: device
- Office Name: Chicago District Office
- Summary: Hatch Product Development LLC, a contract manufacturer and distributor of class II medical devices, was cited with five observations during an FDA inspection. The firm's quality system was found to be severely lacking, with inadequate procedures for corrective and preventive actions, complaint handling, Medical Device Reporting, control of nonconforming material, and finished device acceptance. These deficiencies indicate a systemic failure to maintain proper controls over critical aspects of medical device manufacturing and distribution.

## Related Officers

- [Shuana H. Xiong](https://www.keypedia.com/people/shuana-h-xiong/45ee2b1d-fbb8-452e-a218-8d79e8425fc8)

Company: https://www.keypedia.com/companies/hatch-product-development-llc/f74a7a66-9e81-44ef-a4bb-b68d264e745c

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669