FDA Inspection
TranS1TranS1 – FDA Inspection, Jun 12, 2017
Record Details
This FDA Inspection record concerns TranS1, with an inspection on June 12, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a87e113a-e417-43cb-aced-b3f175a64f3d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1013952
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.160(a)Lack of or inadequate procedures for distribution
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of TranS1
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 11, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 26, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for TranS1
- FDA Inspection 848298 - 2013-09-11
- FDA Inspection 664956 - 2010-05-26
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