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Form 483

Samsung Electronics Form 483, 2016-04-19

FDA issued a Form 483 to Samsung Electronics on 2016-04-19 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

Samsung Electronics · Port Klang, Malaysia · Issued April 19, 2016

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

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

19 Apr 2016
21 CFR 1030.10(c)(3)(i)

tests--errors and uncertainties accounted for

Cited by Michael P Sweeney, Joseph C Teixeira

Inspected site

SESamsung ElectronicsPort Klang, Malaysia

Inspection team

MPMichael P Sweeney
JCJoseph C Teixeira

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1030.10(c)(3)(i)Cited across public-safe Form 483 observations1x

Full 483 report

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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