FDA inspection

Heliora Laboratories Pty Ltd.: FDA inspection ending Jun 21, 2024

FDA inspection 1242880 · Official Action Indicated (OAI) · Osborne Park

Key facts

Inspection ID 1242880
Firm Heliora Laboratories Pty Ltd.
FEI number 3006210769
Address 16 Howe St
City Osborne Park
Country Australia
Fiscal year 2024
Inspection end date Jun 21, 2024
Classification Official Action Indicated (OAI)
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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