FDA Inspection
Transtracheal Systems, Inc.Transtracheal Systems, Inc. – FDA Inspection, Sep 17, 2020
Record Details
This FDA Inspection record concerns Transtracheal Systems, Inc., with an inspection on September 17, 2020, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Transtracheal Systems, Inc.
- Inspection Date
- September 17, 2020
- Product Type
- Devices
View Company Profile
ID · e1a1e09b-93f6-46ca-9b0e-0a456319bb88
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1129440
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.184DHR content
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Transtracheal Systems, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 26, 2019 | 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 1087542 - 2019-04-26
- FDA Inspection 819440 - 2013-02-19
- FDA Inspection 600018 - 2009-07-31
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