# FDA 483 - APN Health LLC - September 01, 2023

Source: https://www.keypedia.com/records/483/apn-health-llc/f6a14edd-d2a2-4e59-a079-3aa7bab009c4

> FDA 483 for APN Health LLC on September 01, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: APN Health LLC
- Inspection Date: 2023-09-01
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: APN Health LLC, a medical device manufacturer in Waukesha, WI, was cited for numerous quality system deficiencies related to its Navik 3D cardiac mapping system. The inspection revealed systemic failures in controlling nonconforming product, managing corrective and preventive actions, handling customer complaints, and ensuring proper labeling. Additionally, the firm lacked adequate procedures for supplier control, finished device acceptance, software validation, design risk analysis, and design change, indicating a broad breakdown in its quality management system.

## Related Documents

- [483 - 2019-10-10](https://www.keypedia.com/records/483/apn-health-llc/d55e871b-9c9f-4463-bb09-d537aaf6f679)

## Related Officers

- [Mildred J. Tures](https://www.keypedia.com/people/mildred-j-tures/c21df23d-580f-4cdc-94a1-194d981e41be)
- [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