FDA inspection

American Regent, Inc.: FDA inspection ending Dec 9, 2022

FDA inspection 1194747 · Official Action Indicated (OAI) · New Albany, OH

Key facts

Inspection ID 1194747
Firm American Regent, Inc.
FEI number 3010209784
Address 6610 New Albany Rd E
City New Albany
State OH
ZIP 43054-8730
Fiscal year 2023
Inspection end date Dec 9, 2022
Classification Official Action Indicated (OAI)
Project area Generic Drug Evaluation
Product type Drugs

At a glance

  • None 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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