Company
United StatesTranstracheal Systems, Inc., Englewood, CO – FDA Inspections
Inspection records and compliance data for Transtracheal Systems, Inc. in Englewood, Colorado. 4 FDA inspections on record, 1 Form 483, last inspected September 17, 2020.
Company Profile
This profile covers Transtracheal Systems, Inc. based in Englewood, Colorado, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 3
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected July 31, 2009. Last inspected September 17, 2020.
Most cited issue areas
- DHR content2 inspections
- Lack of or inadequate complaint procedures2 inspections
- Lack of or inadequate procedures2 inspections
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 17, 2020 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1129440 |
| April 26, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1087542 |
| February 19, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 819440 |
| July 31, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 600018 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Transtracheal Systems, Inc.
FEI Number
1721097
Address
14 Inverness Dr E Ste H100, Englewood, Colorado 80112, United States
Country
United States
ID: f8d29609-2d07-4dfc-a459-b1a926827613