Overview
- 4 public-safe observations are available for this inspection.
- 4 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.
7 Mar 2025
21 CFR 1.504(d)
Document review entity's hazard analysis
Cited by Laura M Lopez, William M Keck
7 Mar 2025
21 CFR 1.506(d)(1)(i)
Verification activity frequency
Cited by Laura M Lopez, William M Keck
7 Mar 2025
21 CFR 1.506(e)(1)(i)(B)
Audit - food safety regulation, plan
Cited by Laura M Lopez, William M Keck
Inspected site
FLFRUITBREEZE LLCMiami, United States
Inspection team
WMWilliam M Keck
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1.504(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1.505(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1.506(d)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1.506(e)(1)(i)(B) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 4 observations
The full inspection record, as Atlas holds it, 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