Overview
- 6 public-safe observations are available for this inspection.
- 3 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
3 Apr 2017
21 CFR 111.135
Quality control operations - product complaints; investigate
Cited by Laura B Kennedy
3 Apr 2017
21 CFR 111.135
Quality control operations - product complaints; investigate
Cited by Laura B Kennedy
3 Apr 2017
21 CFR 111.75(c)(4)
Documentation - specifications met; basis, quality control
Cited by Laura B Kennedy
Inspected site
SISisel International LLCSpringville, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.135 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.65 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(c)(4) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 6 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