FDA inspection

Otsuka ICU Medical LLC: FDA inspection ending Apr 27, 2011

FDA inspection 723658 · Official Action Indicated (OAI) · Austin, TX

Key facts

Inspection ID 723658
Firm Otsuka ICU Medical LLC
FEI number 1628454
Address 3900 Howard Ln
City Austin
State TX
ZIP 78728
Country United States
Fiscal year 2011
Inspection end date Apr 27, 2011
Classification Official Action Indicated (OAI)
Project area Drug Quality Assurance
Product type Drugs

At a glance

  • 10–99 Citations
  • 1–9 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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