FDA inspection

Alkem Laboratories Limited: FDA inspection ending Aug 23, 2019

FDA inspection 1105480 · No Action Indicated (NAI) · Baddi

Key facts

Inspection ID 1105480
Firm Alkem Laboratories Limited
FEI number 3006370533
Address Tehsil Nalagarh
City Baddi
Fiscal year 2019
Inspection end date Aug 23, 2019
Classification No Action Indicated (NAI)
Project area Generic Drug Evaluation
Product type Drugs

At a glance

  • None Citations
  • None 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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