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.
16 Aug 2018
21 CFR 110.10(b)(3)
Not washed/sanitized when appropriate
Cited by Marinee Flores-Marrero, Eduardo Carbonell
16 Aug 2018
21 CFR 110.35(c)
Lack of effective pest exclusion
Cited by Marinee Flores-Marrero, Eduardo Carbonell
16 Aug 2018
21 CFR 110.40(a)
Materials and workmanship
Cited by Marinee Flores-Marrero, Eduardo Carbonell
Inspected site
SISpicepak, Inc.Miami, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.10(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.40(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 4 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