FDA Inspection
JW North America, Inc.JW North America, Inc. – FDA Inspection, Sep 21, 2015
Record Details
This FDA Inspection record concerns JW North America, Inc., with an inspection on September 21, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- JW North America, Inc.
- Inspection Date
- September 21, 2015
- Product Type
- Devices
View Company Profile
ID · af46360d-ce8d-40f0-8e4e-7a84b03b4214
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 944355
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.20(e)Quality System Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of JW North America, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 4, 2025 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 20, 2019 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 22, 2017 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
Other documents for JW North America, Inc.
- FDA Inspection 1294420 - 2025-12-04
- FDA Inspection 1093674 - 2019-06-20
- FDA Inspection 1026370 - 2017-09-22
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