FDA Inspection
Konica Minolta Healthcare, Americas, Inc.Konica Minolta Healthcare, Americas, Inc. – FDA Inspection, Aug 25, 2017
Record Details
This FDA Inspection record concerns Konica Minolta Healthcare, Americas, Inc., with an inspection on August 25, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e08b485d-590f-477b-8038-9344ab7fb8f0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1022872
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
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Other FDA inspections of Konica Minolta Healthcare, Americas, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 20, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Konica Minolta Healthcare, Americas, Inc.
- FDA Inspection 897362 - 2014-08-20
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