FDA inspection

American Regent, Inc.: FDA inspection ending May 5, 2016

FDA inspection 971841 · Voluntary Action Indicated (VAI) · New Albany, OH

Key facts

Inspection ID 971841
Firm American Regent, Inc.
FEI number 3010209784
Address 6610 New Albany Rd E
City New Albany
State OH
ZIP 43054
Country United States
Fiscal year 2016
Inspection end date May 5, 2016
Classification Voluntary Action Indicated (VAI)
Project area Drug Quality Assurance
Product type Drugs

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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