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BARD SHANNON LIMITED FDA Inspection Record

FEI 3005636544 · Inspections, Form 483s, warning letters and import refusals

BARD SHANNON LIMITED is an FDA-registered facility (FEI 3005636544) located in Humacao, PR, US. RegDataLab tracks 6 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Aug 18, 2023: No Action Indicated (NAI)
Inspections on record
6 (1 VAI, 5 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Import refusals
8

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Aug 18, 2023No Action Indicated (NAI)Training - Lack of or inadequate procedures (21 CFR 820.25(b))
Purchasing controls, Lack of or inadequate procedures (21 CFR 820.50)
Environmental control Lack of or inadequate procedures (21 CFR 820.70(c))
Nov 21, 2018Voluntary Action Indicated (VAI)No citations listed
Jan 22, 2016No Action Indicated (NAI)No citations listed
Nov 21, 2013No Action Indicated (NAI)No citations listed
Apr 14, 2010No Action Indicated (NAI)No citations listed
Oct 9, 2009No Action Indicated (NAI)Complete files maintained (21 CFR 820.198(a))
Review and evaluation for investigation (21 CFR 820.198(b))
Investigation of device failures (21 CFR 820.198(c))
Uniform and timely processing (21 CFR 820.198(a)(1))
and 1 more

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
Bard Shannon Limited
Location
Humacao, PR (US)
Source
device

Import refusals

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.