FDA Inspection
Haemotec, a division of Fresenius Medical Care Canada Inc.Haemotec, a division of Fresenius Medical Care Canada Inc. – FDA Inspection, Sep 13, 2012
Record Details
This FDA Inspection record concerns Haemotec, a division of Fresenius Medical Care Canada Inc., with an inspection on September 13, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 13, 2012
- Product Type
- Devices
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ID · bb1b0c5f-9c69-456c-8eb4-08de82b0793e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 802502
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.75(c)Documentation - review in response to changes or deviations
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Other FDA inspections of Haemotec, a division of Fresenius Medical Care Canada Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 12, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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