FDA inspection

Biocon Limited: FDA inspection ending Feb 15, 2019

FDA inspection 1080031 · Official Action Indicated (OAI) · Bengaluru

Key facts

Inspection ID 1080031
Firm Biocon Limited
FEI number 3003981475
Address Special Economic Zone, Plot No. 2, 3, 4&5, Phase Iv, Bommasandra-Jigani Link Road, Bommasandra Post
City Bengaluru
Fiscal year 2019
Inspection end date Feb 15, 2019
Classification Official Action Indicated (OAI)
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
  • 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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