FDA inspection

Alkem Laboratories Limited: FDA inspection ending Feb 21, 2020

FDA inspection 1118336 · Voluntary Action Indicated (VAI) · Tehsil Nalagarh, Baddi

Key facts

Inspection ID 1118336
Firm Alkem Laboratories Limited
FEI number 3006370533
Address Village Thana, Tehsil Nalagarh
City Tehsil Nalagarh, Baddi
Country India
Fiscal year 2020
Inspection end date Feb 21, 2020
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
  • 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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