Form 483

Shun Fung International Trading Inc. Form 483, 2009-07-20

FDA issued a Form 483 to Shun Fung International Trading Inc. on 2009-07-20 with 12 public-safe observations.

483· Form 483 issued12 observations

Shun Fung International Trading Inc. · San Francisco, United States · Issued July 20, 2009

Overview

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

Inspectional observations

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

20 Jul 2009
21 CFR 110.10(b)(9)

Precautions against contamination--micro, foreign substances

Cited by Jeanne A Young, Karen D Phung, Annie H Lam

20 Jul 2009
21 CFR 110.20(b)(1)

Sufficient space

Cited by Jeanne A Young, Karen D Phung, Annie H Lam

20 Jul 2009
21 CFR 110.20(b)(5)

Safety lighting and glass

Cited by Jeanne A Young, Karen D Phung, Annie H Lam

20 Jul 2009
21 CFR 110.35(a)

Buildings/good repair

Cited by Jeanne A Young, Karen D Phung, Annie H Lam

20 Jul 2009
21 CFR 110.35(c)

Lack of effective pest exclusion

Cited by Jeanne A Young, Karen D Phung, Annie H Lam

Inspected site

SFShun Fung International Trading Inc.San Francisco, United States

Inspection team

KDKaren D Phung

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(9)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.35(a)Cited across public-safe Form 483 observations1x
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 110.37(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.37(e)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.37(f)Cited across public-safe Form 483 observations1x
21 CFR 110.80(a)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(7)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 12 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