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DEPUY INTL., LTD. FDA Inspection Record

FEI 1000199976 · Inspections, Form 483s, warning letters and import refusals

DEPUY INTL., LTD. is an FDA-registered facility (FEI 1000199976) located in LEEDS, GB. RegDataLab tracks 4 FDA inspections at this facility.

What FDA found at this site

Latest inspection
May 29, 2026: Voluntary Action Indicated (VAI)
Inspections on record
4 (3 VAI, 1 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
3

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
May 29, 2026Voluntary Action Indicated (VAI)Production controls not adequate (ISO 13485:2016 Clause 7.5.1)
May 26, 2017No Action Indicated (NAI)No citations listed
Jun 25, 2015Voluntary Action Indicated (VAI)Lack of or inadequate procedures (21 CFR 820.100(a))
Design validation - user needs and intended uses (21 CFR 820.30(g))
Feb 16, 2012Voluntary Action Indicated (VAI)Management ensuring quality policy is understood (21 CFR 820.20(a))
Type of Reportable Event (21 CFR 803.52(f)(1))

FDA record score

6 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 15, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

3 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAIMay 29, 20266 x 16
Inspection classified VAIJun 25, 201510 years or older, so it adds no points0
Inspection classified VAIFeb 16, 201210 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 15, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 15, 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 15, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 15, 2026Newest record Nov 5, 2026Current

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Facility details

Company
Depuy International Ltd.
Location
LEEDS (GB)
Source
device

Import refusals

FDA data resources

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