FDA Inspection
Ziehm Imaging Inc.Ziehm Imaging Inc. – FDA Inspection, Aug 2, 2017
Record Details
This FDA Inspection record concerns Ziehm Imaging Inc., with an inspection on August 2, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · fc558f1a-bf07-41d4-8c25-5d3c268b269a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1020077
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 1020.30(d)(1)Report of assembly submitted within 15 days
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
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