# FDA 483 - Tricor Systems - March 08, 2023

Source: https://www.globalkeysolutions.net/records/483/tricor-systems/6a580e53-a5f6-4610-a5f9-f0630c6700a2

> FDA 483 for Tricor Systems on March 08, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tricor Systems
- Inspection Date: 2023-03-08
- Product Type: device
- Office Name: Chicago District Office
- Summary: Tricor Systems, a medical device manufacturer in Elgin, IL, was inspected by the FDA and received a Form 483 with four observations. The inspection revealed significant deficiencies in medical device reporting procedures, supplier controls, employee training, and servicing activity documentation. These issues indicate a need for improved quality system processes to ensure compliance and patient safety.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/tricor-systems/180344dc-f890-42f4-9023-6c911ed1ff15

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