# FDA 483 - Rockford Specialties - September 10, 2019

Source: https://www.globalkeysolutions.net/records/483/rockford-specialties/71bf1a08-f82a-4185-93b0-93ea198042c4

> FDA 483 for Rockford Specialties on September 10, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rockford Specialties
- Inspection Date: 2019-09-10
- Product Type: other
- Office Name: Chicago District Office
- Summary: An FDA inspection of Rockford Specialties, a contract manufacturer in Loves Park, IL, revealed significant deficiencies in its quality management system. The firm failed to appoint a management representative for quality and did not ensure its quality policy was understood or implemented by employees, with one issue being a repeat observation from a previous inspection. These findings indicate a concerning lack of adherence to fundamental quality system requirements.

## Related Officers

- [Medical Device Specialist](https://www.globalkeysolutions.net/people/jesse-a-vazquez/cac5b170-d0ea-4355-af5d-3d81546ff0fe)

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

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