FDA inspection

Apotex Research Private Limited: FDA inspection ending May 20, 2016

FDA inspection 970670 · Voluntary Action Indicated (VAI) · Bengaluru

Key facts

Inspection ID 970670
Firm Apotex Research Private Limited
FEI number 3006076314
Address Plots 1 And 2, Bommasandra Ind. Area, Jigani Link Rd; 4th Phase
City Bengaluru
Country India
Fiscal year 2016
Inspection end date May 20, 2016
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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