Overview
- 11 public-safe observations are available for this inspection.
- 11 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.
2 Dec 2019
21 CFR 117.145(a)
Process Controls Monitoring Procedures: Establish Implement
Cited by Tracy M Portelli, Melissa N Gregorio
2 Dec 2019
21 CFR 117.165(b)
Sanitation Controls Verif Procedures: Establish Implement
Cited by Tracy M Portelli, Melissa N Gregorio
2 Dec 2019
21 CFR 117.20(b)
Plant Construction and Design
Cited by Tracy M Portelli, Melissa N Gregorio
Inspected site
SISirob Imports, Inc.Lindenhurst, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 108.25(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 114.80(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.145(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.165(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.20(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.40(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.405(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.11(a)(1)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.12(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.6(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.8(b)(4) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 11 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