FDA Inspection 1267098 — VitaNorth USA, LLC
The FDA completed an inspection of VitaNorth USA, LLC on April 17, 2025 in Westland, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 13 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 17, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Westland, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15456 | 21 CFR 111.20(b) | Physical plant - space; equipment, materials |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15863 | 21 CFR 111.75(a)(2)(ii)(B) | Component - certificate of analysis |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |
| 15975 | 21 CFR 111.120(e) | Quality control operations - quarantine |
| 15984 | 21 CFR 111.123(a)(8) | Quality control - finished batch, distribution |
| 22818 | 21 CFR 111.10(b) | Hygienic practices |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22888 | 21 CFR 111.210 | Master manufacturing record - record requirements |
| 22897 | 21 CFR 111.325(b) | Make and keep records - laboratory operations |