Overview
- 9 public-safe observations are available for this inspection.
- 9 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 May 2024
21 CFR 117.130(a)(1)
Hazard analysis - Identification of hazard
Cited by Kacie M Crowther, Elaine S Chow, Ngoc B Kelsch, Kimiko G Casuga
15 May 2024
21 CFR 117.135(c)(1)
Process preventive controls - Appropriate (Adequate)
Cited by Kacie M Crowther, Elaine S Chow, Ngoc B Kelsch, Kimiko G Casuga
15 May 2024
21 CFR 117.35(a)
Sanitary operations - Plant sanitation
Cited by Kacie M Crowther, Elaine S Chow, Ngoc B Kelsch, Kimiko G Casuga
15 May 2024
21 CFR 117.35(c)
Pest control
Cited by Kacie M Crowther, Elaine S Chow, Ngoc B Kelsch, Kimiko G Casuga
15 May 2024
21 CFR 117.35(e)
Sanitation of non-food-contact surfaces - Manner and frequency
Cited by Kacie M Crowther, Elaine S Chow, Ngoc B Kelsch, Kimiko G Casuga
Inspected site
FKFong Kee Tofu Co., Inc.San Francisco, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.130(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.135(c)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.35(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.35(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.35(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.80(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.80(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.80(c)(8) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 9 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