FDA inspection

Mallinckrodt, LLC.: FDA inspection ending Apr 4, 2018

FDA inspection 1080875 · Voluntary Action Indicated (VAI) · Bedminster, NJ

Key facts

Inspection ID 1080875
Firm Mallinckrodt, LLC.
FEI number 3014074925
Address 1425 Us Highway 206
City Bedminster
State NJ
ZIP 07921-2653
Fiscal year 2018
Inspection end date Apr 4, 2018
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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