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.
1 Nov 2018
21 CFR 123.11(b)
Sanitation monitoring documentation
Cited by Anabel Veiga, Belisa Acevedo-Hernandez, Lavenia I Donastorg
1 Nov 2018
21 CFR 123.11(b)
Sanitation monitoring documentation
Cited by Anabel Veiga, Belisa Acevedo-Hernandez, Lavenia I Donastorg
1 Nov 2018
21 CFR 123.6(b)
No HACCP plan
Cited by Anabel Veiga, Belisa Acevedo-Hernandez, Lavenia I Donastorg
1 Nov 2018
21 CFR 123.6(b)
No HACCP plan
Cited by Anabel Veiga, Belisa Acevedo-Hernandez, Lavenia I Donastorg
1 Nov 2018
21 CFR 123.6(c)(5)
Corrective action plan
Cited by Anabel Veiga, Belisa Acevedo-Hernandez, Lavenia I Donastorg
Inspected site
JSJOMARA SEAFOOD, INC.Hialeah, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 123.11(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 123.6(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 123.6(c)(5) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 123.8(a)(3) | 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