# FDA 483 - Trident Manufacturing, Inc. - August 28, 2025

Source: https://www.keypedia.com/records/483/trident-manufacturing-inc/056dad70-c889-480e-857e-504be671fc17

> FDA 483 for Trident Manufacturing, Inc. on August 28, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Trident Manufacturing, Inc.
- Inspection Date: 2025-08-28
- Product Type: other
- Office Name: Chicago District Office
- Summary: An FDA inspection of Trident Manufacturing, Inc. in Pingree Grove, IL, revealed significant deficiencies in the firm's quality system. Observations included inadequate procedures for controlling non-conforming product, insufficient complaint handling processes, and a lack of executive approval for the quality policy and objectives. These issues highlight a need for improved documentation, execution, and management oversight within the firm's quality management system.

## Related Officers

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

Company: https://www.keypedia.com/companies/trident-manufacturing-inc/ca7a94c3-03e9-4365-b6dd-44a4a624ed20

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