FDA Inspection
TZ Medical, Inc.TZ Medical, Inc. – FDA Inspection, Oct 20, 2023
Record Details
This FDA Inspection record concerns TZ Medical, Inc., with an inspection on October 20, 2023, issued by the Seattle District Office.
- Company
- TZ Medical, Inc.
- Inspection Date
- October 20, 2023
View Company Profile
ID · 8ab28bbf-c17c-4008-affd-b8f2010695a7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1220694
- FDA center
- Medical Devices & Rad Health
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of TZ Medical, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 3, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 13, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 3, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 26, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 25, 2011 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for TZ Medical, Inc.
- FDA Inspection 1010436 - 2017-05-03
- FDA Inspection 982607 - 2016-07-13
- FDA Inspection 947618 - 2015-11-03
- FDA Inspection 820213 - 2013-02-26
- FDA Inspection 743767 - 2011-08-25
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