FDA-Inspected Site

Synergy Health Sterilization UK Limited

6 FDA inspections are on record for Synergy Health Sterilization UK Limited in Reading, United Kingdom.

483· Form 483 issued

Reading, United Kingdom · Last updated August 15, 2026

Overview

  • 6 FDA inspections are on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2026-06-04.

At a glance

Inspections

6

Form 483s

1

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
1 Jun 2026 – 4 Jun 2026Medical Devices & Rad Health483View 483 →
1 Feb 2012Not recordedClean
25 Jun 2009Not recordedClean
14 Oct 2008Not recordedClean
31 Jul 2003Not recordedClean
18 Jul 2002Not recordedClean

Observations on record

Form 483 observations cited at this site, most recent first.

4 Jun 2026
ISO 13485:2016 Clause 7.1

Product realization risk management processes not documented

Cited by Albert L Nguyen

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
ISO 13485:2016 Clause 7.1Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Synergy Health Sterilization UK Limited's 1 Form 483

Recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat