Company
United StatesAPN Health LLC, Waukesha, WI – FDA Inspections
Inspection records and compliance data for APN Health LLC in Waukesha, Wisconsin. 2 FDA inspections on record, 1 Form 483, last inspected September 01, 2023.
Company Profile
This profile covers APN Health LLC based in Waukesha, Wisconsin, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected October 10, 2019. Last inspected September 1, 2023.
Most cited issue areas
- Lack of or inadequate complaint procedures2 inspections
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design validation - Risk analysis1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 1, 2023 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1216874 |
| October 10, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1106818 |
FDA documents
EIRs (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
APN Health LLC
FEI Number
3014282601
Address
20935 Swenson Dr Ste 160, Waukesha, Wisconsin 53186, United States
Country
United States
ID: 756f8e5c-a3c6-48ea-8063-45e5289fe1c1