FDA Inspection
Cima Technology IncCima Technology Inc – FDA Inspection, Oct 27, 2017
Record Details
This FDA Inspection record concerns Cima Technology Inc, with an inspection on October 27, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 92740d0d-3c4f-42bc-9234-f0761f3b9be1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1030015
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(d)Evaluation, timeliness, identification
- 21 CFR 820.198(d)Records of MDR Investigation
- 21 CFR 820.198(b)Review and evaluation for investigation
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Other FDA inspections of Cima Technology Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 7, 2014 | 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 898476 - 2014-10-07
- FDA Inspection 855486 - 2013-11-12
- FDA Inspection 752988 - 2011-11-09
- FDA Inspection 664661 - 2010-06-02
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