FDA inspection

Biofortuna Limited: FDA inspection ending Jun 15, 2016

FDA inspection 977031 · Voluntary Action Indicated (VAI) · Deeside

Key facts

Inspection ID 977031
Firm Biofortuna Limited
FEI number 3010100862
Address Unit 1, Greenfields Technology Park
City Deeside
Country United Kingdom
Fiscal year 2016
Inspection end date Jun 15, 2016
Classification Voluntary Action Indicated (VAI)
Project area Blood and Blood Products
Product type Biologics

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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