FDA Inspection
JW North America, Inc.JW North America, Inc. – FDA Inspection, Sep 22, 2017
Record Details
This FDA Inspection record concerns JW North America, Inc., with an inspection on September 22, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f768912b-ba7b-4361-8027-214195be5e2b
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1026370
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.50(a)(2)Supplier oversight
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 21, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for JW North America, Inc.
- FDA Inspection 1294420 - 2025-12-04
- FDA Inspection 1093674 - 2019-06-20
- FDA Inspection 944355 - 2015-09-21
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