# FDA 483 - Trigon America LLC - February 13, 2019

Source: https://www.keypedia.com/records/483/trigon-america-llc/af24e25d-9415-4e2b-90e5-2072ad41b86b

> FDA 483 for Trigon America LLC on February 13, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Trigon America LLC
- Inspection Date: 2019-02-13
- Product Type: device
- Office Name: Chicago District Office
- Summary: Trigon International LLC, a medical device manufacturer in Aurora, IL, was inspected by the FDA from February 5-13, 2019. The inspection revealed significant deficiencies in their quality system, including inadequate procedures for finished device acceptance, unvalidated manufacturing processes, and failures in their corrective and preventive action (CAPA) system. Repeat observations were noted for CAPA file maintenance and complaint handling, indicating persistent quality control issues.

## Related Officers

- [Natasha R. Johnson](https://www.keypedia.com/people/natasha-r-johnson/ae9e5ea3-74dd-427e-9f8b-32faa975679e)
- [Investigator](https://www.keypedia.com/people/shafiq-s-ahadi/dd146b0a-ca1c-4052-8f50-4d68e14ad73f)

Company: https://www.keypedia.com/companies/trigon-america-llc/be887f2e-0060-4d38-b44f-b71bd728f526

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