FDA inspection

Merck Serono S.p.A.: FDA inspection ending May 10, 2016

FDA inspection 980565 · Voluntary Action Indicated (VAI) · Modugno

Key facts

Inspection ID 980565
Firm Merck Serono S.p.A.
FEI number 3003581732
Address Via delle Magnolie 15, Loc. Frazione Zona Industriale
City Modugno
Country Italy
Fiscal year 2016
Inspection end date May 10, 2016
Classification Voluntary Action Indicated (VAI)
Project area Drug Quality Assurance
Product type Drugs

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
  • 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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