FDA inspection

Genesys Orthopedics Systems, LLC: FDA inspection ending Sep 8, 2017

FDA inspection 1024529 · Voluntary Action Indicated (VAI) · West Lake Hills, TX

Key facts

Inspection ID 1024529
Firm Genesys Orthopedics Systems, LLC
FEI number 3008455034
Address 1250 S Capital of Texas Hwy Ste 600, Bldg # 3
City West Lake Hills
State TX
ZIP 78746
Country United States
Fiscal year 2017
Inspection end date Sep 8, 2017
Classification Voluntary Action Indicated (VAI)
Project area Compliance: Devices
Product type Devices

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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