Company
United StatesThermotek, Inc., Flower Mound, TX – FDA Inspections
Inspection records and compliance data for Thermotek, Inc. in Flower Mound, Texas. 3 FDA inspections on record, last inspected July 22, 2016.
Company Profile
This profile covers Thermotek, Inc. based in Flower Mound, Texas, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected August 25, 2010. Last inspected July 22, 2016.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 22, 2016 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 981384 |
| November 6, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 855517 |
| August 25, 2010 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 677403 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Thermotek, Inc.
FEI Number
3000204260
Address
1200 Lakeside Pkwy Ste 200, Flower Mound, Texas 75028, United States
Country
United States
ID: 55b779e1-6bed-4acc-b7bd-ae0eb22500be