FDA Inspection
Cima Technology IncCima Technology Inc – FDA Inspection, Oct 7, 2014
Record Details
This FDA Inspection record concerns Cima Technology Inc, with an inspection on October 7, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cima Technology Inc
- Inspection Date
- October 7, 2014
- Product Type
- Devices
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ID · dd2bd878-0cfa-4df0-929a-9d3334bcf9c8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 898476
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.160(b)Distribution records
- 21 CFR 820.198(b)Review and evaluation for investigation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Cima Technology Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 27, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 12, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 9, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 2, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Cima Technology Inc
- FDA Inspection 1030015 - 2017-10-27
- FDA Inspection 855486 - 2013-11-12
- FDA Inspection 752988 - 2011-11-09
- FDA Inspection 664661 - 2010-06-02
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