FDA inspection

BioTE Medical: FDA inspection ending Nov 4, 2016

FDA inspection 991397 · Official Action Indicated (OAI) · Irving, TX

Key facts

Inspection ID 991397
Firm BioTE Medical
FEI number 3012619291
Address 1875 W Walnut Hill Ln Ste 100
City Irving
State TX
ZIP 75038
Country United States
Fiscal year 2017
Inspection end date Nov 4, 2016
Classification Official Action Indicated (OAI)
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
  • Yes 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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