FDA inspection

Thermotek, Inc.: FDA inspection ending Nov 6, 2013

FDA inspection 855517 · Voluntary Action Indicated (VAI) · Flower Mound, TX

Key facts

Inspection ID 855517
Firm Thermotek, Inc.
FEI number 3000204260
Address 1200 Lakeside Pkwy Ste 200
City Flower Mound
State TX
ZIP 75028
Country United States
Fiscal year 2014
Inspection end date Nov 6, 2013
Classification Voluntary Action Indicated (VAI)
Project area Postmarket Assurance: Devices
Product type Devices

At a glance

  • None Citations
  • 1–9 Posted citations
  • No Warning letter followed
  • Yes Form FDA 483 issued
  • No Establishment inspection report (EIR) exists
  • 1–9 Inspections at this FEI

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA inspections

FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.

Source: U.S. Food and Drug Administration (FDA), inspection classification data

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