FDA Inspection
HemoCue ABHemoCue AB – FDA Inspection, May 31, 2018
Record Details
This FDA Inspection record concerns HemoCue AB, with an inspection on May 31, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · db416814-882f-4940-9399-11a7cf2a31a1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1055264
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.50(a)(2)Supplier oversight
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Other FDA inspections of HemoCue AB
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 20, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 26, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for HemoCue AB
- FDA Inspection 825448 - 2013-03-20
- FDA Inspection 750673 - 2011-10-26
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