Overview
- 5 public-safe observations are available for this inspection.
- 5 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.
26 Apr 2023
21 CFR 106.100(e)(3)
Monitoring - actual values, deviations, corrections, person
Cited by Amy L Mcintyre, Karen M Labounty, Rebecca L Keller
26 Apr 2023
21 CFR 106.10(a)
Qualified personnel to perform operations
Cited by Amy L Mcintyre, Karen M Labounty, Rebecca L Keller
26 Apr 2023
21 CFR 106.30(b)
Equipment, utensil - clean, sanitize
Cited by Amy L Mcintyre, Karen M Labounty, Rebecca L Keller
26 Apr 2023
21 CFR 106.30(f)
Clean, sanitize, maintain equipment & utensils
Cited by Amy L Mcintyre, Karen M Labounty, Rebecca L Keller
26 Apr 2023
21 CFR 106.55(a)
System of process controls to prevent adulteration
Cited by Amy L Mcintyre, Karen M Labounty, Rebecca L Keller
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 106.10(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 106.100(e)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 106.30(b) | 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 |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 5 observations
The source PDF, 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