FDA inspection

Sterigenics Shanghai E Beam Ltd.: FDA inspection ending Aug 3, 2023

FDA inspection 1217176 · No Action Indicated (NAI) · Shanghai

Key facts

Inspection ID 1217176
Firm Sterigenics Shanghai E Beam Ltd.
FEI number 3008132411
Address A603 Lane, No 588 Chuantu Road, Chuansha Pudong
City Shanghai
Fiscal year 2023
Inspection end date Aug 3, 2023
Classification No Action Indicated (NAI)
Project area Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: 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Product type Devices

At a glance

  • None Citations
  • None 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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