FDA inspection

Bard Shannon Limited: FDA inspection ending Aug 18, 2023

FDA inspection 1215173 · Voluntary Action Indicated (VAI) · Rio Abajo HUMACAO, PR

Key facts

Inspection ID 1215173
Firm Bard Shannon Limited
FEI number 3005636544
Address San Geronimo Industrial Park, Lot No. 1 Road No. 3 Km. 79.7
City Rio Abajo HUMACAO
State PR
ZIP 00791
Country United States
Fiscal year 2023
Inspection end date Aug 18, 2023
Classification Voluntary Action Indicated (VAI)
Project area Postmarket Assurance: Devices
Product type Devices

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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