Atlas

Form 483

Sharp Appliances Ltd. Form 483, 2017-05-04

FDA issued a Form 483 to Sharp Appliances Ltd. on 2017-05-04 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Sharp Appliances Ltd. · Bangpakong, Thailand · Issued May 4, 2017

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

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

Inspected site

SASharp Appliances Ltd.Bangpakong, Thailand

Inspection team

GMGregory M Bessette
MPMichael P Sweeney

Cited regulations

CFR citations associated with this Form 483.

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

Full 483 report

Get the verbatim text of all 2 observations

Every observation in full, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere