FDA inspection

Harps Europe Manufacturing: FDA inspection ending May 28, 2010

FDA inspection 669646 · Voluntary Action Indicated (VAI) · Wimpassing Im Schwarzatale

Key facts

Inspection ID 669646
Firm Harps Europe Manufacturing
FEI number 3007478974
Address Bundesstrase 26
City Wimpassing Im Schwarzatale
Country Austria
Fiscal year 2010
Inspection end date May 28, 2010
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
  • 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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