FDA Inspection 1101165 — One Solution, LLC dba Complete Packaging & Manufacturing
The FDA completed an inspection of One Solution, LLC dba Complete Packaging & Manufacturing on September 5, 2019 in Orem, UT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 5, 2019
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Orem, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15831 | 21 CFR 111.70(b)(3) | Specifications - contamination limits |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15864 | 21 CFR 111.75(a)(2)(ii)(C) | Documentation - qualify supplier |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |
| 16071 | 21 CFR 111.35(b)(3) | Documentation - instruments, controls; calibrations |