Form 483

Fong Kee Tofu Co., Inc. Form 483, 2025-07-15

FDA issued a Form 483 to Fong Kee Tofu Co., Inc. on 2025-07-15 with 5 public-safe observations.

483· Form 483 issuedFoods & Cosmetics5 observations

Fong Kee Tofu Co., Inc. · San Francisco, United States · Issued July 15, 2025

Overview

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

Inspectional observations

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

15 Jul 2025
21 CFR 117.130(a)(1)

Hazard analysis - Identification of hazard

Cited by Lillian C Hsu, Elaine S Chow, Jane G Choi, Lilia K Vazquez

15 Jul 2025
21 CFR 117.135(a)(1)

Sanitation preventive controls - Implement

Cited by Lillian C Hsu, Elaine S Chow, Jane G Choi, Lilia K Vazquez

15 Jul 2025
21 CFR 117.135(c)(1)

Process preventive controls - Appropriate (Adequate)

Cited by Lillian C Hsu, Elaine S Chow, Jane G Choi, Lilia K Vazquez

15 Jul 2025
21 CFR 117.35(a)

Sanitary operations - Plant sanitation

Cited by Lillian C Hsu, Elaine S Chow, Jane G Choi, Lilia K Vazquez

15 Jul 2025
21 CFR 117.35(c)

Pest control

Cited by Lillian C Hsu, Elaine S Chow, Jane G Choi, Lilia K Vazquez

Inspected site

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

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.130(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 117.135(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 117.135(c)(1)Cited across public-safe Form 483 observations1x
21 CFR 117.35(a)Cited across public-safe Form 483 observations1x
21 CFR 117.35(c)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 observations

The full inspection record, as Atlas holds it, 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