FDA inspection

Ortho-Clinical Diagnostics, Inc.: FDA inspection ending Sep 17, 2003

FDA inspection 294163 · No Action Indicated (NAI) · Rochester, NY

Key facts

Inspection ID 294163
Firm Ortho-Clinical Diagnostics, Inc.
FEI number 1000136573
Address 100 Indigo Creek Dr
City Rochester
State NY
ZIP 14626-5101
Fiscal year 2003
Inspection end date Sep 17, 2003
Classification No Action Indicated (NAI)
Project area Product Evaluation: Med Devices
Product type Devices

At a glance

  • None Citations
  • None Posted citations
  • No Warning letter followed
  • Yes Form FDA 483 issued
  • Yes 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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