Atlas

FDA-Inspected Site

Sharp Appliances Ltd.

5 FDA inspections are on record for Sharp Appliances Ltd. in Bangpakong, Thailand.

Clean· No action indicated

Bangpakong, Thailand · Last updated July 9, 2026

Overview

  • 5 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2024-10-28.

At a glance

Inspections

5

Form 483s

2

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
28 Oct 2024Medical Devices & Rad HealthClean
23 May 2023 – 24 May 2023Medical Devices & Rad Health483View 483 →
4 May 2017Medical Devices & Rad Health483View 483 →
20 May 2011Not recordedClean
23 Mar 2009Not recordedClean

Observations on record

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

24 May 2023
21 CFR 1010.2(c)

Certification not based on adequate test/testing program

Cited by Gregory M Bessette, Nassim Ben Makhlouf

24 May 2023
21 CFR 1030.10(c)(3)(i)

tests--errors and uncertainties accounted for

Cited by Gregory M Bessette, Nassim Ben Makhlouf

24 May 2023
21 CFR 1030.10(c)(3)(iii)

Measurements with tap water container

Cited by Gregory M Bessette, Nassim Ben Makhlouf

4 May 2017
21 CFR 1010.2(c)

Certification not based on adequate test/testing program

Cited by Gregory M Bessette, Michael P Sweeney

4 May 2017
21 CFR 1030.10(c)(2)(v)

Secondary safety interlock failure

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.
Goushi Kubota1 insp.
Nassim Ben Makhlouf1 insp.
Michael P Sweeney1 insp.
Emir Galevi1 insp.
Andre S Lamontagne1 insp.
Joseph C Teixeira1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 1010.2(c)Cited across public-safe Form 483 observations2x
21 CFR 1030.10(c)(2)(v)Cited across public-safe Form 483 observations1x
21 CFR 1030.10(c)(3)(i)Cited across public-safe Form 483 observations1x
21 CFR 1030.10(c)(3)(iii)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Sharp Appliances Ltd.'s 2 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