FDA Inspection
Abbott Point of Care Canada LimitedAbbott Point of Care Canada Limited – FDA Inspection, May 12, 2017
Record Details
This FDA Inspection record concerns Abbott Point of Care Canada Limited, with an inspection on May 12, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · df1f91bd-15b0-41c7-a688-3247c212b391
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1019209
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Abbott Point of Care Canada Limited
7| Date | Classification | Office | Project area |
|---|---|---|---|
| September 19, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 19, 2022 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 20, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 5, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 2, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Abbott Point of Care Canada Limited
- FDA Inspection 1251759 - 2024-09-19
- FDA Inspection 1176613 - 2022-05-19
- FDA Inspection 1010306 - 2016-10-20
- FDA Inspection 862058 - 2013-12-05
- FDA Inspection 705411 - 2010-12-02
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