FDA inspection

Elementis Pharma GmbH: FDA inspection ending Jan 26, 2016

FDA inspection 959004 · Voluntary Action Indicated (VAI) · Ludwigshafen Am Rhein

Key facts

Inspection ID 959004
Firm Elementis Pharma GmbH
FEI number 3002807069
Address Giulinistr. 2
City Ludwigshafen Am Rhein
Country Germany
Fiscal year 2016
Inspection end date Jan 26, 2016
Classification Voluntary Action Indicated (VAI)
Project area Drug Quality Assurance
Product type Drugs

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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