Form 483

Sung Won Inc. of Columbia Form 483, 2016-09-06

FDA issued a Form 483 to Sung Won Inc. of Columbia on 2016-09-06 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Sung Won Inc. of Columbia · Columbia, United States · Issued September 6, 2016

Overview

4 public-safe observations are available for this inspection.
4 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.

6 Sep 2016

21 CFR 110.20(b)(6)

Fans/air blowing equipment

Cited by Valeria A Moore, Charles E Idjagboro

6 Sep 2016

21 CFR 110.35(c)

Lack of effective pest exclusion

Cited by Valeria A Moore, Charles E Idjagboro

6 Sep 2016

21 CFR 110.35(d)(5)

Shown to be effective

Cited by Valeria A Moore, Charles E Idjagboro

6 Sep 2016

21 CFR 110.80(b)(1)

Maintenance of equip., utensils, and finished food packaging

Cited by Valeria A Moore, Charles E Idjagboro

Inspected site

SWSung Won Inc. of ColumbiaColumbia, United States

Inspection team

VAValeria A Moore

CECharles E Idjagboro

Cited regulations

CFR citations associated with this Form 483.

Citation	What it covers	Cited
21 CFR 110.20(b)(6)	Cited across public-safe Form 483 observations	1x
21 CFR 110.35(c)	Cited across public-safe Form 483 observations	1x
21 CFR 110.35(d)(5)	Cited across public-safe Form 483 observations	1x
21 CFR 110.80(b)(1)	Cited across public-safe Form 483 observations	1x

Full 483 report

Get the verbatim text of all 4 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