Overview
- 6 public-safe observations are available for this inspection.
- 6 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
19 Nov 2021
21 CFR 117.130(a)(1)
Hazard Analysis - Identification of Hazard
Cited by Ellen M Landis, Dana A Razzano, Joshua D Lopez
19 Nov 2021
21 CFR 117.145(a)
Sanitation Controls Monitoring Proced: Establish Implement
Cited by Ellen M Landis, Dana A Razzano, Joshua D Lopez
19 Nov 2021
21 CFR 117.165(a)(4)
Process preventive controls - Record review
Cited by Ellen M Landis, Dana A Razzano, Joshua D Lopez
19 Nov 2021
21 CFR 117.165(b)
Sanitation Controls Verif Procedures: Establish Implement
Cited by Ellen M Landis, Dana A Razzano, Joshua D Lopez
19 Nov 2021
21 CFR 117.40
Equipment and utensils - Design and maintenance
Cited by Ellen M Landis, Dana A Razzano, Joshua D Lopez
Inspected site
SSStewart's Shops Corp.Saratoga Springs, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.130(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(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.165(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.415(a)(2) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 6 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