FDA inspection

Merck Serono S.p.A.: FDA inspection ending Jul 1, 2011

FDA inspection 733934 · Official Action Indicated (OAI) · Guidonia Montecelio

Key facts

Inspection ID 733934
Firm Merck Serono S.p.A.
FEI number 3002807252
Address Via Luigi Einaudi 11
City Guidonia Montecelio
Country Italy
Fiscal year 2011
Inspection end date Jul 1, 2011
Classification Official Action Indicated (OAI)
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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