FDA Inspection
Ottawa Dental Laboratory LtdOttawa Dental Laboratory Ltd – FDA Inspection, Apr 2, 2014
Record Details
This FDA Inspection record concerns Ottawa Dental Laboratory Ltd, with an inspection on April 2, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Ottawa Dental Laboratory Ltd
- Inspection Date
- April 2, 2014
- Product Type
- Devices
View Company Profile
ID · 42f589e9-b280-4e12-8e51-d03c2d5e550b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 872111
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.80(e)Documentation
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.40(a)Document review, approval documentation
- 21 CFR 820.20(c)Management review dates
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Ottawa Dental Laboratory Ltd
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 19, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Ottawa Dental Laboratory Ltd
- FDA Inspection 1029976 - 2017-07-19
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