FDA inspection

Coretex Products Inc.: FDA inspection ending Nov 2, 2015

FDA inspection 946394 · Voluntary Action Indicated (VAI) · Erwin, TN

Key facts

Inspection ID 946394
Firm Coretex Products Inc.
FEI number 3002719565
Address 1850 Sunnyside Ct
City Erwin
State TN
ZIP 37650
Country United States
Fiscal year 2016
Inspection end date Nov 2, 2015
Classification Voluntary Action Indicated (VAI)
Project area Drug Quality Assurance
Product type Drugs

At a glance

  • 1–9 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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