FDA inspection

Galentic Pharma (India) Pvt. Ltd: FDA inspection ending Feb 21, 2018

FDA inspection 1045052 · Voluntary Action Indicated (VAI) · Gandhidham

Key facts

Inspection ID 1045052
Firm Galentic Pharma (India) Pvt. Ltd
FEI number 3012178852
Address Plots 5B & 5C, Sector III, Kandla SEZ
City Gandhidham
Country India
Fiscal year 2018
Inspection end date Feb 21, 2018
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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