# FDA 483 - IntriCon Corp - April 17, 2023

Source: https://www.globalkeysolutions.net/records/483/intricon-corp/aa438798-8ac2-483a-af72-ca5620128dea

> FDA 483 for IntriCon Corp on April 17, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: IntriCon Corp
- Inspection Date: 2023-04-17
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of IntriCon Corp, a contract manufacturer in Vadnais Heights, MN, revealed inadequate procedures for preventing contamination and handling contaminated product. The firm experienced multiple contamination incidents involving medical device components, failing to properly document review, approval, and disposition of affected products or work areas. This indicates a significant lapse in quality control and contamination prevention protocols.

## Related Officers

- [Albert L. Nguyen](https://www.globalkeysolutions.net/people/albert-l-nguyen/496338d0-71c4-43da-92f0-09515559d9fc)

Company: https://www.globalkeysolutions.net/companies/intricon-corp/39f0e161-9706-4084-a255-3bde3210ecf5

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d