FDA inspection

Innovative Sterilization Technologies LLC: FDA inspection ending Nov 4, 2015

FDA inspection 950174 · Official Action Indicated (OAI) · Dayton, OH

Key facts

Inspection ID 950174
Firm Innovative Sterilization Technologies LLC
FEI number 3010772758
Address 7625 Paragon Rd Ste A
City Dayton
State OH
ZIP 45459
Country United States
Fiscal year 2016
Inspection end date Nov 4, 2015
Classification Official Action Indicated (OAI)
Project area Postmarket Assurance: Devices
Product type Devices
Warning letter 485178

At a glance

  • 1–9 Citations
  • 1–9 Posted citations
  • Yes 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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