FDA Inspection
Transtracheal Systems, Inc.Transtracheal Systems, Inc. – FDA Inspection, Apr 26, 2019
Record Details
This FDA Inspection record concerns Transtracheal Systems, Inc., with an inspection on April 26, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 9ae89cc3-d125-4f33-9965-b04922637a89
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1087542
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.184DHR content
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Transtracheal Systems, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 17, 2020 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 19, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 31, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Transtracheal Systems, Inc.
- FDA Inspection 1129440 - 2020-09-17
- FDA Inspection 819440 - 2013-02-19
- FDA Inspection 600018 - 2009-07-31
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