FDA Inspection
Sintx Technologies IncSintx Technologies Inc – FDA Inspection, May 9, 2014
Record Details
This FDA Inspection record concerns Sintx Technologies Inc, with an inspection on May 9, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Sintx Technologies Inc
- Inspection Date
- May 9, 2014
- Product Type
- Devices
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ID · 81f3d7f0-7517-4beb-aea5-77c8d318449d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 879329
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
8- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
- 21 CFR 820.40(b)Change records, content
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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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 13, 2011 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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