FDA Inspection
ThyssenKrupp Access Manufacturing, LLCThyssenKrupp Access Manufacturing, LLC – FDA Inspection, Nov 10, 2011
Record Details
This FDA Inspection record concerns ThyssenKrupp Access Manufacturing, LLC, with an inspection on November 10, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 10, 2011
- Product Type
- Devices
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ID · 7f1ec128-3bfd-4c35-80d3-3493c5d4f39d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 754208
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.50(a)(1)Documented evaluation
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Other FDA inspections of ThyssenKrupp Access Manufacturing, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 6, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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