FDA Inspection
Thinking Systems Corp.Thinking Systems Corp. – FDA Inspection, Aug 10, 2011
Record Details
This FDA Inspection record concerns Thinking Systems Corp., with an inspection on August 10, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Thinking Systems Corp.
- Inspection Date
- August 10, 2011
- Product Type
- Devices
View Company Profile
ID · 935a6ae1-ce47-4c5a-a68c-057c64fe8758
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 738767
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.30(g)Design validation acceptance criteria
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.30(g)Design validation - documentation
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Thinking Systems Corp.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 31, 2018 | Not classified | Florida District Office | |
| September 10, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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