FDA inspection

EPflex Feinwerktechnik GmbH: FDA inspection ending Jun 13, 2013

FDA inspection 839372 · Official Action Indicated (OAI) · Dettingen An Der Erms

Key facts

Inspection ID 839372
Firm EPflex Feinwerktechnik GmbH
FEI number 3003289691
Address Im Schwollbogen 24
City Dettingen An Der Erms
Country Germany
Fiscal year 2013
Inspection end date Jun 13, 2013
Classification Official Action Indicated (OAI)
Project area Compliance: Devices
Product type Devices
Warning letter 409621

At a glance

  • 1–9 Citations
  • 1–9 Posted citations
  • Yes 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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