FDA inspection

Leica Biosystems Newcastle Ltd.: FDA inspection ending Jan 25, 2019

FDA inspection 1093975 · Voluntary Action Indicated (VAI) · Newcastle Upon Tyne

Key facts

Inspection ID 1093975
Firm Leica Biosystems Newcastle Ltd.
FEI number 3004859032
Address Balliol Business Park, Benton Lane
City Newcastle Upon Tyne
Fiscal year 2019
Inspection end date Jan 25, 2019
Classification Voluntary Action Indicated (VAI)
Project area Compliance: Medical Devices
Product type Devices

At a glance

  • None Citations
  • 1–9 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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