FDA inspection

Bard Shannon Limited: FDA inspection ending Nov 21, 2018

FDA inspection 1072328 · Voluntary Action Indicated (VAI) · Rio Abajo HUMACAO, PR

Key facts

Inspection ID 1072328
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 2019
Inspection end date Nov 21, 2018
Classification Voluntary Action Indicated (VAI)
Project area Compliance: Devices
Product type Devices

At a glance

  • None 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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