FDA inspection

Amneal Pharmaceuticals Private: FDA inspection ending May 12, 2025

FDA inspection 1269875 · Official Action Indicated (OAI) · Sanand

Key facts

Inspection ID 1269875
Firm Amneal Pharmaceuticals Private
FEI number 3029456823
Address 16 17 Plot No 15, Sarkhej - Bavla N H No 8a; Vil: Matoda
City Sanand
Fiscal year 2025
Inspection end date May 12, 2025
Classification Official Action Indicated (OAI)
Project area Generic Drug Evaluation
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
  • 1–9 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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