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.
2 Apr 2021
21 CFR 117.130(a)(2)
Hazard Analysis - Written
Cited by Karla J Gibler, Phillip J Sample, Anna L Viveros-Hernandez, Breena L D'Ambrogi
2 Apr 2021
21 CFR 117.35(a)
Sanitary Operations - Plant Maintenance
Cited by Karla J Gibler, Phillip J Sample, Anna L Viveros-Hernandez, Breena L D'Ambrogi
2 Apr 2021
21 CFR 117.80(a)(2)
Appropriate quality control operations
Cited by Karla J Gibler, Phillip J Sample, Anna L Viveros-Hernandez, Breena L D'Ambrogi
2 Apr 2021
21 CFR 117.80(c)
Manufacturing, Processing, Packing, Holding - Controls
Cited by Karla J Gibler, Phillip J Sample, Anna L Viveros-Hernandez, Breena L D'Ambrogi
2 Apr 2021
n/a
Procedural requirements
Cited by Karla J Gibler, Phillip J Sample, Anna L Viveros-Hernandez, Breena L D'Ambrogi
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)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.35(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.80(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.80(c) | Cited across public-safe Form 483 observations | 1x |
| n/a | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
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Full 483 report
Get the verbatim text of all 5 observations
The source PDF, 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