Home / Facilities / 3002807907

PENLON LTD. FDA Inspection Record

FEI 3002807907 · Inspections, Form 483s, warning letters and import refusals

PENLON LTD. is an FDA-registered facility (FEI 3002807907) located in ABINGDON Oxfordshire, GB. RegDataLab tracks 4 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Dec 12, 2024: No Action Indicated (NAI)
Inspections on record
4 (2 VAI, 2 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
Recalls as the recalling firm
1, latest May 14, 2013
Import refusals
2

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
Dec 12, 2024No Action Indicated (NAI)No citations listed
Jul 14, 2022Voluntary Action Indicated (VAI)No citations listed
Sep 13, 2018Voluntary Action Indicated (VAI)Lack of or inadequate receiving acceptance procedures (21 CFR 820.80(b))
Investigation of device failures (21 CFR 820.198(c))
Jul 28, 2011No Action Indicated (NAI)Design validation - Risk analysis (21 CFR 820.30(g))
Lack of or inadequate procedures (21 CFR 820.100(a))
DMR device specifications (21 CFR 820.181(a))
Investigation of device failures (21 CFR 820.198(c))
and 3 more

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
May 14, 2013Class IIZ-1653-2013Delta Vaporizer An anesthetic vaporizer is a device used to vaporize liquid anesthetic…
It has come to Penlon Ltd's attention of an instance where the installation and pre-use checks listed in the User Manual may not have been…

FDA record score

5 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 14, 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 VAIJul 14, 20226 x 0.63.6
Inspection classified VAISep 13, 20186 x 0.251.5
Class II recall Z-1653-2013, this FEI as the recalling firmMay 14, 201310 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 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

Reviewing PENLON LTD. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check PENLON LTD. yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

Facility details

Company
Penlon Limited
Location
ABINGDON Oxfordshire (GB)
Source
device

Import refusals

FDA data resources

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