FDA Inspection
Sintx Technologies IncSintx Technologies Inc – FDA Inspection, May 13, 2011
Record Details
This FDA Inspection record concerns Sintx Technologies Inc, with an inspection on May 13, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Sintx Technologies Inc
- Inspection Date
- May 13, 2011
- Product Type
- Devices
View Company Profile
ID · 7b52015d-3e47-4f70-8421-f9ccf18deea7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 724895
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 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 820.72(b)Calibration procedures - content
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Sintx Technologies Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 10, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 9, 2014 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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