FDA Inspection
JW North America, Inc.JW North America, Inc. – FDA Inspection, Nov 15, 2018
Record Details
This FDA Inspection record concerns JW North America, Inc., with an inspection on November 15, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 19fb1cbb-b5d5-4772-b4f1-bab370e2145d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1071829
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 1010.3(a)(1)ID label lacks name and address
Full citation text and observation details available on the Dashboard.
Other FDA inspections of JW North America, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 25, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for JW North America, Inc.
- FDA Inspection 1031326 - 2017-10-25
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