FDA inspection

PT. GALENIUM PHARMASIA LABORATORIES: FDA inspection ending Sep 12, 2014

FDA inspection 908707 · Voluntary Action Indicated (VAI) · Jakarta Selatan

Key facts

Inspection ID 908707
Firm PT. GALENIUM PHARMASIA LABORATORIES
FEI number 3005157144
Address Jln. Aditiawarman I 67
City Jakarta Selatan
Country Indonesia
Fiscal year 2014
Inspection end date Sep 12, 2014
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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