FDA Inspection
PAJUNK GMBH MEDIZINTECHNOLOGIEPAJUNK GMBH MEDIZINTECHNOLOGIE – FDA Inspection, Jan 31, 2013
Record Details
This FDA Inspection record concerns PAJUNK GMBH MEDIZINTECHNOLOGIE, with an inspection on January 31, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- January 31, 2013
- Product Type
- Devices
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ID · 51782ce5-7f94-4bbc-9393-45711eb0ee6d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 818828
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
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Other FDA inspections of PAJUNK GMBH MEDIZINTECHNOLOGIE
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 6, 2025 | Not classified | Office of Inspections and Investigations | |
| December 17, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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