FDA inspection

Alkem Laboratories Limited: FDA inspection ending Oct 25, 2013

FDA inspection 854604 · Voluntary Action Indicated (VAI) · Daman

Key facts

Inspection ID 854604
Firm Alkem Laboratories Limited
FEI number 3006370524
Address 167 Mahatma Gandhi Udyog Nagar Road
City Daman
Country India
Fiscal year 2014
Inspection end date Oct 25, 2013
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
  • 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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