Overview
- 8 public-safe observations are available for this inspection.
- 4 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
10 Oct 2019
21 CFR 117.130(a)(1)
Hazard Analysis - Identification of Hazard
Cited by Shanna R Haden, Esther A Ofori, Michael A Feingold
10 Oct 2019
21 CFR 117.130(a)(1)
Hazard Analysis - Identification of Hazard
Cited by Shanna R Haden, Esther A Ofori, Michael A Feingold
10 Oct 2019
21 CFR 117.145(a)
Process Controls Monitoring Procedures: Establish Implement
Cited by Shanna R Haden, Esther A Ofori, Michael A Feingold
10 Oct 2019
21 CFR 117.145(a)
Process Controls Monitoring Procedures: Establish Implement
Cited by Shanna R Haden, Esther A Ofori, Michael A Feingold
10 Oct 2019
21 CFR 117.80(b)(4)
Raw materials and Rework Controls - Filth and Contamination
Cited by Shanna R Haden, Esther A Ofori, Michael A Feingold
Inspected site
SISinzenard International Food Manufacturer, LLCSaint Louis, 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 | 2x |
| 21 CFR 117.145(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 117.80(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 123.6(b) | 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