FDA Inspection
Syntec Scientific CorporationSyntec Scientific Corporation – FDA Inspection, Dec 18, 2014
Record Details
This FDA Inspection record concerns Syntec Scientific Corporation, with an inspection on December 18, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 18, 2014
- Product Type
- Devices
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ID · db681d1f-d834-4f31-a01d-385ea2a8ea01
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 908743
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
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Other FDA inspections of Syntec Scientific Corporation
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 26, 2026 | Not classified | Office of Inspections and Investigations | |
| May 5, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 13, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 1, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Syntec Scientific Corporation
- FDA Inspection 1315936 - 2026-03-26
- FDA Inspection 1207360 - 2023-05-05
- FDA Inspection 1081598 - 2018-12-13
- FDA Inspection 671677 - 2010-07-01
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