FDA inspection

Alkem Laboratories Limited: FDA inspection ending Jul 31, 2015

FDA inspection 939486 · Voluntary Action Indicated (VAI) · Tehsil Nalagarh, Baddi

Key facts

Inspection ID 939486
Firm Alkem Laboratories Limited
FEI number 3006370533
Address Village Thana, Tehsil Nalagarh
City Tehsil Nalagarh, Baddi
Country India
Fiscal year 2015
Inspection end date Jul 31, 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
  • 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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