FDA inspection

Genesis Biologics, Inc.: FDA inspection ending May 25, 2012

FDA inspection 783686 · Voluntary Action Indicated (VAI) · Irvine, CA

Key facts

Inspection ID 783686
Firm Genesis Biologics, Inc.
FEI number 3008066433
Address 16782 Von Karman Ave Ste 17
City Irvine
State CA
ZIP 92614
Country United States
Fiscal year 2012
Inspection end date May 25, 2012
Classification Voluntary Action Indicated (VAI)
Project area Human Cellular, Tissue, and Gene Therapies
Product type Biologics

At a glance

  • 10–99 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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