# Rockford Specialties – FDA 483, Apr 29, 2026

Source: https://www.keypedia.com/records/483/rockford-specialties/37dff3bc-8b26-45e7-9824-d0c710393c85

> FDA 483 for Rockford Specialties on April 29, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rockford Specialties
- Inspection Date: 2026-04-29
- Product Type: device
- Office Name: Chicago District Office
- Summary: Rockford Acquisition Company, LLC in Loves Park, IL, a contract manufacturer of Class II medical devices, was cited for significant deficiencies in its quality management system. The inspection revealed a lack of documented and maintained procedures for critical processes such as risk management, process validation, equipment qualification, complaint handling, preventive actions, and data analysis. These findings indicate a fundamental breakdown in the firm's ability to ensure product quality and regulatory compliance.

## Related Documents

- [483 - 2019-09-10](https://www.keypedia.com/records/483/rockford-specialties/71bf1a08-f82a-4185-93b0-93ea198042c4) — date: September 10, 2019

## Related Officers

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

Company: https://www.keypedia.com/companies/rockford-specialties/489395cc-debe-4021-b091-16aff7ec1e57

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