FDA Inspection
ThyssenKrupp Access CorpThyssenKrupp Access Corp – FDA Inspection, Apr 10, 2012
Record Details
This FDA Inspection record concerns ThyssenKrupp Access Corp, with an inspection on April 10, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ThyssenKrupp Access Corp
- Inspection Date
- April 10, 2012
- Product Type
- Devices
View Company Profile
ID · 4f94a395-2a8e-4d80-96d8-f4edef748ad2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 777303
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.198(a)Complaints
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.198(b)Rationale documented for no investigation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of ThyssenKrupp Access Corp
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 8, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 10, 2011 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 5, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for ThyssenKrupp Access Corp
- FDA Inspection 843541 - 2013-08-08
- FDA Inspection 714462 - 2011-03-10
- FDA Inspection 601903 - 2009-08-05
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