FDA Inspection
Transonic Systems IncTransonic Systems Inc – FDA Inspection, Feb 1, 2018
Record Details
This FDA Inspection record concerns Transonic Systems Inc, with an inspection on February 1, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b0f41e84-e83c-4c92-94ec-b36db1c00a7d
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1040245
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.250(b)Sampling methods - Lack of or inadequate procedures
- 21 CFR 820.50(a)(2)Supplier oversight
- 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 |
|---|---|---|---|
| June 16, 2017 | VAI | Center for Devices and Radiological Health | Compliance: 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 1015982 - 2017-06-16
- FDA Inspection 860000 - 2013-11-19
- FDA Inspection 823936 - 2013-03-21
- FDA Inspection 643524 - 2010-01-26
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