FDA Inspection
Wolf X-Ray CorpWolf X-Ray Corp – FDA Inspection, May 8, 2018
Record Details
This FDA Inspection record concerns Wolf X-Ray Corp, with an inspection on May 8, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 5d0b21f1-b6a5-4167-9317-0e972f9db0e5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1051321
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.80(e)Documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Wolf X-Ray Corp
6| Date | Classification | Office | Project area |
|---|---|---|---|
| March 14, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 7, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 1, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 24, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 24, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Wolf X-Ray Corp
- FDA Inspection 1046334 - 2018-03-14
- FDA Inspection 933484 - 2015-07-07
- FDA Inspection 820732 - 2013-03-01
- FDA Inspection 731640 - 2011-06-24
- FDA Inspection 731630 - 2011-06-24
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