FDA Inspection
Haemoscope Division of Haemonetics CorpHaemoscope Division of Haemonetics Corp – FDA Inspection, Sep 9, 2010
Record Details
This FDA Inspection record concerns Haemoscope Division of Haemonetics Corp, with an inspection on September 9, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 9, 2010
- Product Type
- Devices
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ID · f09ddcef-35bb-4b6b-b263-5daf62e9bda5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 680387
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
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Other FDA inspections of Haemoscope Division of Haemonetics Corp
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 15, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 24, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Haemoscope Division of Haemonetics Corp
- FDA Inspection 968353 - 2016-04-15
- FDA Inspection 834307 - 2013-05-24
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