# FDA 483 - APN Health LLC - October 10, 2019

Source: https://www.keypedia.com/records/483/apn-health-llc/d55e871b-9c9f-4463-bb09-d537aaf6f679

> FDA 483 for APN Health LLC on October 10, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: APN Health LLC
- Inspection Date: 2019-10-10
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: APN Health LLC, a medical device manufacturer in Waukesha, WI, was cited with two observations on a Form FDA 483. The inspection revealed significant deficiencies in the firm's design verification procedures for its Navik 3D software and its complaint handling processes. These issues indicate a failure to adequately establish and follow internal quality system procedures.

## Related Documents

- [483 - 2023-09-01](https://www.keypedia.com/records/483/apn-health-llc/f6a14edd-d2a2-4e59-a079-3aa7bab009c4)

## Related Officers

- [investigator](https://www.keypedia.com/people/michelle-j-glembin/e58f4652-d09f-41a7-941d-335c7b5338ad)

Company: https://www.keypedia.com/companies/apn-health-llc/756f8e5c-a3c6-48ea-8063-45e5289fe1c1

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