FDA inspection

Sterigenics US, LLC: FDA inspection ending Oct 25, 2022

FDA inspection 1190626 · No Action Indicated (NAI) · Charlotte, NC

Key facts

Inspection ID 1190626
Firm Sterigenics US, LLC
FEI number 1000219637
Address 10811 Withers Cove Park Dr Ste D
City Charlotte
State NC
ZIP 28278
Country United States
Fiscal year 2023
Inspection end date Oct 25, 2022
Classification No Action Indicated (NAI)
Project area Compliance: Devices
Product type Devices

At a glance

  • None Citations
  • None Posted citations
  • No Warning letter followed
  • Yes Form FDA 483 issued
  • Yes Establishment inspection report (EIR) exists
  • 10–99 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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