FDA Inspection
Thinking Systems Corp.Thinking Systems Corp. – FDA Inspection, Sep 10, 2014
Record Details
This FDA Inspection record concerns Thinking Systems Corp., with an inspection on September 10, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Thinking Systems Corp.
- Inspection Date
- September 10, 2014
- Product Type
- Devices
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ID · d54f4da9-fe69-4d64-9dad-b95474a3cb55
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 894755
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
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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 | |
| August 10, 2011 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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