FDA Inspection
Karl Storz Video Endoscopy Estonia OUKarl Storz Video Endoscopy Estonia OU – FDA Inspection, Oct 11, 2012
Record Details
This FDA Inspection record concerns Karl Storz Video Endoscopy Estonia OU, with an inspection on October 11, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 11, 2012
- Product Type
- Devices
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ID · ed6a0c1c-5003-489b-adb7-64c777cc80ca
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 806286
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Karl Storz Video Endoscopy Estonia OU
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 17, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Karl Storz Video Endoscopy Estonia OU
- FDA Inspection 1195352 - 2022-11-17
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