FDA Inspection
Hans Rudolph IncHans Rudolph Inc – FDA Inspection, Feb 22, 2017
Record Details
This FDA Inspection record concerns Hans Rudolph Inc, with an inspection on February 22, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 885fcc1e-93ac-44bf-8c28-dbd62720bef0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1002408
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of Hans Rudolph Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 7, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 4, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Hans Rudolph Inc
- FDA Inspection 853640 - 2013-10-07
- FDA Inspection 634965 - 2009-12-04
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