Form 483

LG Electronics Inc. Form 483, 2015-06-24

FDA issued a Form 483 to LG Electronics Inc. on 2015-06-24 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

LG Electronics Inc. · Tianjin, China · Issued June 24, 2015

Overview

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

Inspectional observations

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

24 Jun 2015
21 CFR 1030.10(c)(3)(i)

tests--errors and uncertainties accounted for

Cited by Michael P Sweeney, Joseph C Teixeira, Mark K Tseng

Inspected site

LELG Electronics Inc.Tianjin, China

Inspection team

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