Overview
- 45 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.
29 Dec 2015
21 CFR 123.6(c)(6)
Verification procedures - adequacy
Cited by John J Bernal, Michael C Lombardi
29 Dec 2015
21 CFR 123.8(a)(3)
Verification - record review - frequency
Cited by John J Bernal, Michael C Lombardi
Inspected site
SJSt. James Smokehouse, Inc.Miami, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.80(b)(2) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 123.12(a)(2) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 123.6(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 123.6(c)(1) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 123.6(c)(2) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 123.6(c)(3) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 123.6(c)(5) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 123.6(c)(6) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 123.8(a)(3) | Cited across public-safe Form 483 observations | 5x |
Full 483 report
Get the verbatim text of all 45 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