FDA inspection

Argenta US Manufacturing LLC: FDA inspection ending Nov 1, 2013

FDA inspection 853861 · Voluntary Action Indicated (VAI) · Shawnee, KS

Key facts

Inspection ID 853861
Firm Argenta US Manufacturing LLC
FEI number 1910953
Address 12707 Shawnee Mission Pkwy
City Shawnee
State KS
ZIP 66216
Country United States
Fiscal year 2014
Inspection end date Nov 1, 2013
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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