FDA Inspection 1283318 — NuPack Inc
The FDA completed an inspection of NuPack Inc on Sep 24, 2025 in Elgin, IL. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Sep 24, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Elgin, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15433 | 21 CFR 111.15(d)(1) | Animals and pests in facility |
| 15447 | 21 CFR 111.15(c)(3) | Cleaning compounds and toxic materials - holding |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15646 | 21 CFR 111.460(a) | Hold, identify - in-process material |
| 22818 | 21 CFR 111.10(b) | Hygienic practices |
| 22823 | 21 CFR 111.15(b) | Physical plant - clean and sanitary |
| 22831 | 21 CFR 111.20(d) | Physical plant - construction |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22884 | 21 CFR 111.205(a) | Master manufacturing record - prepared |
| 22900 | 21 CFR 111.403 | Written procedures - establish; packaging & labeling |
| 22908 | 21 CFR 111.503 | Written procedures - establish; returned dietary supplements |