FDA Inspection
ThyssenKrupp Access CorpThyssenKrupp Access Corp – FDA Inspection, Mar 10, 2011
Record Details
This FDA Inspection record concerns ThyssenKrupp Access Corp, with an inspection on March 10, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ThyssenKrupp Access Corp
- Inspection Date
- March 10, 2011
- Product Type
- Devices
View Company Profile
ID · e1fbd724-fa7e-41f3-91b2-154d9d0cb5fe
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 714462
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.25(b)Training records
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
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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 |
| April 10, 2012 | VAI | 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 777303 - 2012-04-10
- FDA Inspection 601903 - 2009-08-05
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