FDA Inspection
Geister Medizintecknik GmbhGeister Medizintecknik Gmbh – FDA Inspection, Mar 27, 2014
Record Details
This FDA Inspection record concerns Geister Medizintecknik Gmbh, with an inspection on March 27, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Geister Medizintecknik Gmbh
- Inspection Date
- March 27, 2014
- Product Type
- Devices
View Company Profile
ID · d662ee53-3f07-42e6-a19b-25060a8a5959
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 894795
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
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Other FDA inspections of Geister Medizintecknik Gmbh
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 26, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Geister Medizintecknik Gmbh
- FDA Inspection 1019976 - 2016-10-26
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