FDA inspection

Datascope Corp.: FDA inspection ending Feb 2, 2023

FDA inspection 1197368 · Fairfield, NJ

Key facts

Inspection ID 1197368
Firm Datascope Corp.
FEI number 1000222374
Address 15 Law Dr Unit 1
City Fairfield
State NJ
ZIP 07004-3206
Fiscal year 2023
Inspection end date Feb 2, 2023
Project area Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: 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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