FDA inspection

Amneal Pharmaceuticals Pvt. Ltd.: FDA inspection ending May 24, 2019

FDA inspection 1091111 · Voluntary Action Indicated (VAI) · Bavla

Key facts

Inspection ID 1091111
Firm Amneal Pharmaceuticals Pvt. Ltd.
FEI number 3008223599
Address 882/1 - 871, Village Rajoda, Taluka Bavla
City Bavla
Country India
Fiscal year 2019
Inspection end date May 24, 2019
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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