FDA inspection

Coloplast Manufacturing US, LLC: FDA inspection ending Sep 28, 2011

FDA inspection 744306 · Voluntary Action Indicated (VAI) · Minneapolis, MN

Key facts

Inspection ID 744306
Firm Coloplast Manufacturing US, LLC
FEI number 2125050
Address 1601 W River Rd
City Minneapolis
State MN
ZIP 55411
Country United States
Fiscal year 2011
Inspection end date Sep 28, 2011
Classification Voluntary Action Indicated (VAI)
Project area Compliance: Devices
Product type Devices

At a glance

  • 1–9 Citations
  • 1–9 Posted citations
  • No Warning letter followed
  • Yes Form FDA 483 issued
  • Yes 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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