Atlas

FDA-Inspected Site

Sharp U.K. Manufacturing (SUKM)

3 FDA inspections are on record for Sharp U.K. Manufacturing (SUKM) in Wrexham, United Kingdom.

483· Form 483 issued

Wrexham, United Kingdom · Last updated July 10, 2026

Overview

  • 3 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2022-11-02.

At a glance

Inspections

3

Form 483s

3

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
1 Nov 2022 – 2 Nov 2022Medical Devices & Rad Health483View 483 →
23 Apr 2018Medical Devices & Rad Health483View 483 →
3 May 2016Medical Devices & Rad Health483View 483 →

Observations on record

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

2 Nov 2022
21 CFR 1010.2(c)

Certification not based on adequate test/testing program

Cited by Gregory M Bessette, Francis Pham

2 Nov 2022
21 CFR 1030.10(c)(3)(i)

tests--errors and uncertainties accounted for

Cited by Gregory M Bessette, Francis Pham

23 Apr 2018
21 CFR 1010.2(c)

Certification not based on adequate test/testing program

Cited by Gregory M Bessette, Michael P Sweeney

23 Apr 2018
21 CFR 1030.10(c)(3)(i)

tests--errors and uncertainties accounted for

Cited by Gregory M Bessette, Michael P Sweeney

23 Apr 2018
21 CFR 1030.10(c)(3)(iv)

Door position

Cited by Gregory M Bessette, Michael P Sweeney

Investigators

FDA investigators tied to this site in the record.

Gregory M Bessette2 insp.
Francis Pham1 insp.
Michael P Sweeney1 insp.
Joseph C Teixeira1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 1030.10(c)(3)(i)Cited across public-safe Form 483 observations3x
21 CFR 1010.2(c)Cited across public-safe Form 483 observations2x
21 CFR 1030.10(c)(3)(iii)Cited across public-safe Form 483 observations1x
21 CFR 1030.10(c)(3)(iv)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Sharp U.K. Manufacturing (SUKM)'s 3 Form 483s

Verbatim observations and 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