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ENERGIST LIMITED FDA Inspection Record

FEI 3007353760 · Inspections, Form 483s, warning letters and import refusals

ENERGIST LIMITED is an FDA-registered facility (FEI 3007353760) located in Swansea, GB. RegDataLab tracks 3 FDA inspections and 1 compliance action at this facility.

What FDA found at this site

Latest inspection
Dec 5, 2024: No Action Indicated (NAI)
Inspections on record
3 (1 OAI, 2 NAI)
Last OAI inspection
May 24, 2012
Warning letters
1 listed by FDA for this FEI, latest Dec 4, 2012
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 5, 2024No Action Indicated (NAI)No citations listed
Sep 18, 2014No Action Indicated (NAI)Design transfer - Lack of or inadequate procedures (21 CFR 820.30(h))
May 24, 2012Official Action Indicated (OAI)DHR - not or inadequately maintained (21 CFR 820.184)
Training - Lack of or inadequate procedures (21 CFR 820.25(b))
Design validation- Lack of or inadequate procedures (21 CFR 820.30(g))
Documentation (21 CFR 820.75(a))
and 2 more

FDA record score

0 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.

2 records behind this number
RecordDatePoints x age weightAdds
Warning letter on FDA's dashboard, which does not show close-outsDec 4, 201210 years or older, so it adds no points0
Inspection classified OAIMay 24, 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
ENERGIST LIMITED
Location
Swansea (GB)
Source
device

Compliance actions

Import refusals

FDA data resources

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