FDA inspection

ISOVAC Products, LLC: FDA inspection ending May 11, 2023

FDA inspection 1205029 · Voluntary Action Indicated (VAI) · Romeoville, IL

Key facts

Inspection ID 1205029
Firm ISOVAC Products, LLC
FEI number 3006076009
Address 1306 Enterprise Dr Ste C
City Romeoville
State IL
ZIP 60446
Country United States
Fiscal year 2023
Inspection end date May 11, 2023
Classification Voluntary Action Indicated (VAI)
Project area Postmarket Assurance: 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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