FDA inspection

Aurora Manufacturing LLC: FDA inspection ending Oct 31, 2016

FDA inspection 993759 · Voluntary Action Indicated (VAI) · Indianapolis, IN

Key facts

Inspection ID 993759
Firm Aurora Manufacturing LLC
FEI number 3005529226
Address 104 N Shore Dr
City Indianapolis
State IN
ZIP 46250
Country United States
Fiscal year 2017
Inspection end date Oct 31, 2016
Classification Voluntary Action Indicated (VAI)
Project area Compliance: 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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