Overview
- 5 public-safe observations are available for this inspection.
- 5 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
14 Aug 2012
21 CFR 110.93
Storage/transportation of finished goods (contamination)
Cited by Jason D Tenney
14 Aug 2012
21 CFR 120.8(b)(3)
HACCP plan - critical limits not listed or not adequate
Cited by Jason D Tenney
14 Aug 2012
21 CFR 120.8(b)(5)
HACCP plan - corrective action plan not included
Cited by Jason D Tenney
Inspected site
SBSunshine Bottling Co, Inc.Doral, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.35(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.93 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.11(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.8(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.8(b)(5) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 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