FDA Inspection
JW North America, Inc.JW North America, Inc. – FDA Inspection, Jun 20, 2019
Record Details
This FDA Inspection record concerns JW North America, Inc., with an inspection on June 20, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c51f9289-9611-4271-a860-b3ad9705ad0a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1093674
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
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 |
| September 22, 2017 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| 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 1026370 - 2017-09-22
- FDA Inspection 944355 - 2015-09-21
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