FDA Inspection
Abbott LaboratoriesAbbott Laboratories – FDA Inspection, Aug 10, 2016
Record Details
This FDA Inspection record concerns Abbott Laboratories, with an inspection on August 10, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Abbott Laboratories
- Inspection Date
- August 10, 2016
- Product Type
- Devices
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ID · 8954c192-e1fa-4777-b842-3c4ca3508075
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 986276
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Abbott Laboratories
4| Date | Classification | Office | Project area |
|---|---|---|---|
| May 17, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 16, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 1, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 12, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Abbott Laboratories
- FDA Inspection 1017182 - 2017-05-17
- FDA Inspection 834101 - 2013-05-16
- FDA Inspection 716720 - 2011-04-01
- FDA Inspection 605426 - 2009-08-12
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