Form 483

Sewon Food Co., LTD Form 483, 2016-06-14

FDA issued a Form 483 to Sewon Food Co., LTD on 2016-06-14 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Sewon Food Co., LTD · Gwangju-si, Korea (the Republic of) · Issued June 14, 2016

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.

14 Jun 2016
21 CFR 114.10

Personnel

Cited by Vien Q Le

14 Jun 2016
21 CFR 114.80(b)

Code - required elements

Cited by Vien Q Le

14 Jun 2016
21 CFR 114.80(a)(2)

pH testing

Cited by Vien Q Le

Inspected site

SFSewon Food Co., LTDGwangju-si, Korea (the Republic of)

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 114.10Cited across public-safe Form 483 observations1x
21 CFR 114.80(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 114.80(b)Cited 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