Overview
- 8 public-safe observations are available for this inspection.
- 4 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 Sep 2015
21 CFR 110.35(a)
Buildings/sanitary
Cited by Elodie X Tong-Lin, Andrew E Kay, James C Lee, Elodie X Tong Lin
15 Sep 2015
21 CFR 110.35(a)
Buildings/sanitary
Cited by Elodie X Tong-Lin, Andrew E Kay, James C Lee, Elodie X Tong Lin
15 Sep 2015
21 CFR 110.80
Reasonable precautions
Cited by Elodie X Tong-Lin, Andrew E Kay, James C Lee, Elodie X Tong Lin
15 Sep 2015
21 CFR 110.80
Reasonable precautions
Cited by Elodie X Tong-Lin, Andrew E Kay, James C Lee, Elodie X Tong Lin
15 Sep 2015
21 CFR 110.80(b)(1)
Teardown equipment/thorough cleaning
Cited by Elodie X Tong-Lin, Andrew E Kay, James C Lee, Elodie X Tong Lin
Inspected site
SFSogo Foods Inc.San Jose, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.35(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.80 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.80(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.80(b)(2) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 8 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