Form 483

LG Electronics Inc. Form 483, 2010-05-18

FDA issued a Form 483 to LG Electronics Inc. on 2010-05-18 with 1 public-safe observation.

483· Form 483 issued1 observation

LG Electronics Inc. · Tianjin, China · Issued May 18, 2010

Overview

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

Inspectional observations

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

18 May 2010
21 CFR 1010.2(c)

Certification not based on adequate test/testing program

Cited by Andre S Lamontagne

Inspected site

LELG Electronics Inc.Tianjin, China

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1010.2(c)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