FDA inspection

Amneal Oncology Private Limited: FDA inspection ending Jun 8, 2016

FDA inspection 976423 · Voluntary Action Indicated (VAI) · Hyderabad

Key facts

Inspection ID 976423
Firm Amneal Oncology Private Limited
FEI number 3005903939
Address Plot No. S-3, S-4, S-5A, APIIC SEZ, Polepally, Jedcherla, Mehboobnagar Dist.
City Hyderabad
Fiscal year 2016
Inspection end date Jun 8, 2016
Classification Voluntary Action Indicated (VAI)
Project area Generic Drug Evaluation
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
  • 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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