FDA Inspection 681405 — WellnessOne, Inc.
The FDA completed an inspection of WellnessOne, Inc. on Sep 17, 2010 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). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 17, 2010
- Fiscal Year
- 2010
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Andover, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |