FDA inspection

Ensign Laboratories Proprietary Ltd: FDA inspection ending Jul 15, 2022

FDA inspection 1175015 · Voluntary Action Indicated (VAI) · Mulgrave

Key facts

Inspection ID 1175015
Firm Ensign Laboratories Proprietary Ltd
FEI number 3003380641
Address 490-500 Wellington Rd
City Mulgrave
Country Australia
Fiscal year 2022
Inspection end date Jul 15, 2022
Classification Voluntary Action Indicated (VAI)
Project area Drug Quality Assurance
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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