FDA Inspection
Cima Technology IncCima Technology Inc – FDA Inspection, Nov 12, 2013
Record Details
This FDA Inspection record concerns Cima Technology Inc, with an inspection on November 12, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cima Technology Inc
- Inspection Date
- November 12, 2013
- Product Type
- Devices
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ID · 5ad12a95-e2a6-4212-9dff-651351379d70
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 855486
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.30(j)Design history file
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 |
| October 7, 2014 | 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 898476 - 2014-10-07
- FDA Inspection 752988 - 2011-11-09
- FDA Inspection 664661 - 2010-06-02
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