FDA inspection

Fresenius U.S.A. Manufacturing, Inc.: FDA inspection ending Dec 27, 2012

FDA inspection 809863 · Voluntary Action Indicated (VAI) · Oregon, OH

Key facts

Inspection ID 809863
Firm Fresenius U.S.A. Manufacturing, Inc.
FEI number 1527681
Address 750 N Lallendorf Rd
City Oregon
State OH
ZIP 43616
Country United States
Fiscal year 2013
Inspection end date Dec 27, 2012
Classification Voluntary Action Indicated (VAI)
Project area Postmarket Assurance: 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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