Form 483

Fong Kee Tofu Co., Inc. Form 483, 2015-04-03

FDA issued a Form 483 to Fong Kee Tofu Co., Inc. on 2015-04-03 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Fong Kee Tofu Co., Inc. · San Francisco, United States · Issued April 3, 2015

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.

3 Apr 2015
21 CFR 110.20(b)(4)

Floors, walls and ceilings

Cited by Courtney R Bolton, Joseph Tibay

3 Apr 2015
21 CFR 110.35(a)

Cleaning and sanitizing operations

Cited by Courtney R Bolton, Joseph Tibay

3 Apr 2015
21 CFR 110.35(c)

Lack of effective pest exclusion

Cited by Courtney R Bolton, Joseph Tibay

3 Apr 2015
21 CFR 110.80(b)(1)

Maintenance of equip., utensils, and finished food packaging

Cited by Courtney R Bolton, Joseph Tibay

Inspected site

FKFong Kee Tofu Co., Inc.San Francisco, United States

Inspection team

CRCourtney R Bolton

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.20(b)(4)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 110.80(b)(1)Cited across public-safe Form 483 observations1x

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