Atlas

Form 483

Foshan Gaunying Electronics Co., Ltd Form 483, 2014-11-20

FDA issued a Form 483 to Foshan Gaunying Electronics Co., Ltd on 2014-11-20 with 3 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health3 observations

Foshan Gaunying Electronics Co., Ltd · Foshan, China · Issued November 20, 2014

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

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

20 Nov 2014
21 CFR 820.30(e)

Design review - Lack of or inadequate procedures

Cited by Amy M Cramer

20 Nov 2014
21 CFR 820.40

Procedures not adequately established or maintained

Cited by Amy M Cramer

20 Nov 2014
21 CFR 820.100(b)

Documentation

Cited by Amy M Cramer

Inspected site

FGFoshan Gaunying Electronics Co., LtdFoshan, China

Inspection team

AMAmy M Cramer

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(b)Cited across public-safe Form 483 observations1x
21 CFR 820.30(e)Cited across public-safe Form 483 observations1x
21 CFR 820.40Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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