Overview
- 9 public-safe observations are available for this inspection.
- 9 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
5 Jun 2009
21 CFR 110.37(e)
Running water at suitable temperature
Cited by Sara J Dent Acosta, Gabriel Craig
5 Jun 2009
21 CFR 120.8(b)(1)
HACCP plan - food hazards not listed
Cited by Sara J Dent Acosta, Gabriel Craig
5 Jun 2009
21 CFR 120.8(b)(2)
HACCP plan - critical control points not listed
Cited by Sara J Dent Acosta, Gabriel Craig
Inspected site
TMTropicana Manufacturing Company, Inc.City Of Industry, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.37(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.10(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.11(a)(1)(iv)(A) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.12(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.6(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.6(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.8(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.8(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.8(b)(4) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 9 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