FDA inspection

Zydus Lifesciences Limited: FDA inspection ending May 3, 2019

FDA inspection 1088772 · Official Action Indicated (OAI) · Sanand

Key facts

Inspection ID 1088772
Firm Zydus Lifesciences Limited
FEI number 3002984011
Address 419 & 420 8a Village-Moraiya
City Sanand
Country India
Fiscal year 2019
Inspection end date May 3, 2019
Classification Official Action Indicated (OAI)
Project area Drug Quality Assurance
Product type Drugs
Warning letter 584856

At a glance

  • 10–99 Citations
  • 1–9 Posted citations
  • Yes 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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