# FDA 483 - PROXIMAGEN LLC - March 05, 2019

Source: https://www.keypedia.com/records/483/proximagen-llc/f647d077-fea4-4af2-b59e-a25e742fa28b

> FDA 483 for PROXIMAGEN LLC on March 05, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PROXIMAGEN LLC
- Inspection Date: 2019-03-05
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Proximagen LLC in Plymouth, MN, revealed multiple deficiencies in the firm's quality system and manufacturing controls. The company failed to establish adequate design control procedures for its Nayzilam device, lacked proper monitoring for process parameters, and did not have procedures for identifying valid statistical techniques. Additionally, a management representative was not timely appointed, and quality agreements with contract manufacturers were not clearly defined regarding services.

## Related Officers

- [Deputy Commissioner for Foods](https://www.keypedia.com/people/james-k-ireland/78658286-3e62-4069-a8e1-b157aa77c7fe)
- [investigator](https://www.keypedia.com/people/susan-m-matthias/cd23c465-4411-4988-8676-2089e265622a)

Company: https://www.keypedia.com/companies/proximagen-llc/7964c75a-2e7c-4b2f-a219-841c8489efbe

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