FDA Inspection
Ziehm Imaging GmbhZiehm Imaging Gmbh – FDA Inspection, Feb 17, 2017
Record Details
This FDA Inspection record concerns Ziehm Imaging Gmbh, with an inspection on February 17, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Andrew Saunders
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ID · f01297db-5910-4998-9813-bebb17da8ef2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1006562
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 1010.3(a)(2)ID label lacks place, month & year of manufacture
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
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Other FDA inspections of Ziehm Imaging Gmbh
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 7, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 28, 2012 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Ziehm Imaging Gmbh
- FDA Inspection 892023 - 2014-08-07
- FDA Inspection 791614 - 2012-06-28
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