Form 483

Shun Fung International Trading Inc. Form 483, 2010-04-07

FDA issued a Form 483 to Shun Fung International Trading Inc. on 2010-04-07 with 9 public-safe observations.

483· Form 483 issued9 observations

Shun Fung International Trading Inc. · San Francisco, United States · Issued April 7, 2010

Overview

  • 9 public-safe observations are available for this inspection.
  • 9 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.

7 Apr 2010
21 CFR 110.10(b)(6)

Failure to wear

Cited by Henry K Lau, Lydia S Chan, Andrew B Slarve

7 Apr 2010
21 CFR 110.10(b)(8)

Personal food/drink/tobacco

Cited by Henry K Lau, Lydia S Chan, Andrew B Slarve

7 Apr 2010
21 CFR 110.10(b)(9)

Precautions against contamination--micro, foreign substances

Cited by Henry K Lau, Lydia S Chan, Andrew B Slarve

7 Apr 2010
21 CFR 110.10(c)

Training of handlers and supervisors

Cited by Henry K Lau, Lydia S Chan, Andrew B Slarve

7 Apr 2010
21 CFR 110.20(b)(1)

Sufficient space

Cited by Henry K Lau, Lydia S Chan, Andrew B Slarve

Inspected site

SFShun Fung International Trading Inc.San Francisco, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(8)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(9)Cited across public-safe Form 483 observations1x
21 CFR 110.10(c)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)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.35(b)(2)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

Full 483 report

Get the verbatim text of all 9 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