Form 483

Shun Lee Inc. Form 483, 2016-04-06

FDA issued a Form 483 to Shun Lee Inc. on 2016-04-06 with 1 public-safe observation.

483· Form 483 issuedFoods & Cosmetics1 observation

Shun Lee Inc. · San Francisco, United States · Issued April 6, 2016

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 3 investigators are tied to this Form 483.

Inspectional observations

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

6 Apr 2016
21 CFR 110.35(c)

Lack of effective pest exclusion

Cited by Sara M Richardson, Thomas N Adjabeng, Megan E Kulas

Inspected site

SLShun Lee Inc.San Francisco, United States

Inspection team

SMSara M Richardson

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

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