FDA inspection

Wayne Concept Manufacturing Co., Inc.: FDA inspection ending Jan 10, 2013

FDA inspection 814166 · Voluntary Action Indicated (VAI) · Fort Wayne, IN

Key facts

Inspection ID 814166
Firm Wayne Concept Manufacturing Co., Inc.
FEI number 3002251297
Address 5005 Speedway Dr
City Fort Wayne
State IN
ZIP 46825
Country United States
Fiscal year 2013
Inspection end date Jan 10, 2013
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
  • Yes 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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