FDA inspection

Genesis Biosystems, Inc: FDA inspection ending Jun 1, 2015

FDA inspection 928343 · Official Action Indicated (OAI) · Lewisville, TX

Key facts

Inspection ID 928343
Firm Genesis Biosystems, Inc
FEI number 3003427273
Address 1500 Eagle Ct
City Lewisville
State TX
ZIP 75057
Country United States
Fiscal year 2015
Inspection end date Jun 1, 2015
Classification Official Action Indicated (OAI)
Project area Compliance: 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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