Overview
- 4 public-safe observations are available for this inspection.
- 4 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.
13 Feb 2026
21 CFR 106.30(e)(2)(i)
Cold storage areas - 40 degrees F
Cited by Elizabeth P Mayer, Stephen G Mclane
13 Feb 2026
21 CFR 106.30(f)
Clean, sanitize, maintain equipment & utensils
Cited by Elizabeth P Mayer, Stephen G Mclane
13 Feb 2026
21 CFR 106.55(a)
System of process controls to prevent adulteration
Cited by Elizabeth P Mayer, Stephen G Mclane
Inspected site
PWPerrigo Wisconsin, LLCEau Claire, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 106.30(e)(2)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 106.30(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 106.55(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.10 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 4 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