FDA Inspection 1198144 — VitaNorth USA, LLC
The FDA completed an inspection of VitaNorth USA, LLC on February 22, 2023 in Westland, MI. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 22, 2023
- Fiscal Year
- 2023
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Westland, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15388 | 21 CFR 111.10(b) | Personnel - hygienic practices |
| 15580 | 21 CFR 111.155(c)(2) | Quality control - components; tests, examination results |
| 15643 | 21 CFR 111.455(b) | Hold - adversely affected |
| 15645 | 21 CFR 111.455(c) | Hold - mix-up, contamination, deterioration |
| 15646 | 21 CFR 111.460(a) | Hold, identify - in-process material |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15865 | 21 CFR 111.75(a)(2)(ii)(D) | Re-confirm certificate of analysis |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15886 | 21 CFR 111.77(b) | Specifications not met - identity; component, reject |