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Form 483

LG Electronics Inc. Form 483, 2017-05-10

FDA issued a Form 483 to LG Electronics Inc. on 2017-05-10 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

LG Electronics Inc. · Tianjin, China · Issued May 10, 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.

10 May 2017
21 CFR 1010.2(c)

Certification not based on adequate test/testing program

Cited by Gregory M Bessette, Michael P Sweeney

10 May 2017
21 CFR 1030.10(c)(2)(vi)

Means to monitor interlocks

Cited by Gregory M Bessette, Michael P Sweeney

Inspected site

LELG Electronics Inc.Tianjin, China

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)(vi)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