FDA inspection

Repligen Corporation: FDA inspection ending Jan 13, 2022

FDA inspection 1161778 · No Action Indicated (NAI) · Irving, TX

Key facts

Inspection ID 1161778
Firm Repligen Corporation
FEI number 1625657
Address 3400 Royalty Row
City Irving
State TX
ZIP 75062-4946
Fiscal year 2022
Inspection end date Jan 13, 2022
Classification No Action Indicated (NAI)
Project area Compliance: Medical Devices
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
  • 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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