FDA Inspection
Transonic Systems IncTransonic Systems Inc – FDA Inspection, Jun 16, 2017
Record Details
This FDA Inspection record concerns Transonic Systems Inc, with an inspection on June 16, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 8fe72704-6e24-4fd7-8f03-b18ec0298776
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1015982
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Transonic Systems Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 1, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 19, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 21, 2013 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 26, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Transonic Systems Inc
- FDA Inspection 1040245 - 2018-02-01
- FDA Inspection 860000 - 2013-11-19
- FDA Inspection 823936 - 2013-03-21
- FDA Inspection 643524 - 2010-01-26
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