FDA Inspection
Cambridge Sensors LimitedCambridge Sensors Limited – FDA Inspection, Jul 19, 2012
Record Details
This FDA Inspection record concerns Cambridge Sensors Limited, with an inspection on July 19, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cambridge Sensors Limited
- Inspection Date
- July 19, 2012
- Product Type
- Devices
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ID · 6436637e-b8ec-434b-bc0a-e1b24dbf18d9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 799290
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.40(b)Document change records, maintained.
- 21 CFR 820.70(i)Software validation for automated processes
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Other FDA inspections of Cambridge Sensors Limited
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 10, 2019 | Not classified | Office of Inspections and Investigations | Compliance: Devices |
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