Overview
- 10 public-safe observations are available for this inspection.
- 5 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.
Inspected site
JSJoseph Shalhoub & Son, Inc.Brooklyn, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.20(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.20(b)(5) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.37(d)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.37(e)(5) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.80(b)(1) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 10 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