FDA Inspection 1098602 — WellnessOne, Inc.
The FDA completed an inspection of WellnessOne, Inc. on Aug 2, 2019 in Andover, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 2, 2019
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Andover, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15533 | 21 CFR 111.255(c) | Batch record - follow master |
| 15754 | 21 CFR 111.210(a) | Master manufacturing record - dietary ingredients |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15849 | 21 CFR 111.73 | Specifications met - contamination limits |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |