FDA inspection

Purac Biochem BV: FDA inspection ending Dec 11, 2015

FDA inspection 954945 · Voluntary Action Indicated (VAI) · Gorinchem

Key facts

Inspection ID 954945
Firm Purac Biochem BV
FEI number 3002806633
Address Arkelse Onderweg 46, P.O. Box 21
City Gorinchem
Country Netherlands
Fiscal year 2016
Inspection end date Dec 11, 2015
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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