FDA inspection

Serum Institute of India Private Ltd.: FDA inspection ending Apr 19, 2022

FDA inspection 1175967 · Voluntary Action Indicated (VAI) · Pune

Key facts

Inspection ID 1175967
Firm Serum Institute of India Private Ltd.
FEI number 3020223359
Address S No 105-110
City Pune
Country India
Fiscal year 2022
Inspection end date Apr 19, 2022
Classification Voluntary Action Indicated (VAI)
Project area Vaccines and Allergenic Products
Product type Biologics

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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