FDA inspection

IsoTis OrthoBiologics, Inc.: FDA inspection ending Nov 21, 2001

FDA inspection 197803 · No Action Indicated (NAI) · Irvine, CA

Key facts

Inspection ID 197803
Firm IsoTis OrthoBiologics, Inc.
FEI number 3001503333
Address 2 Goodyear Ste A
City Irvine
State CA
ZIP 92618-2052
Fiscal year 2002
Inspection end date Nov 21, 2001
Classification No Action Indicated (NAI)
Project area Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies
Product type Biologics, Devices, Drugs

At a glance

  • None Citations
  • None Posted citations
  • No Warning letter followed
  • Yes Form FDA 483 issued
  • No Establishment inspection report (EIR) exists
  • 10–99 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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