FDA Inspection 1300024 — TKS Co-Pack Manufacturing, LLC
The FDA completed an inspection of TKS Co-Pack Manufacturing, LLC on Jan 27, 2026 in Lindon, UT. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- Jan 27, 2026
- Fiscal Year
- 2026
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Lindon, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15864 | 21 CFR 111.75(a)(2)(ii)(C) | Documentation - qualify supplier |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |
| 15955 | 21 CFR 111.113(a)(3) | Quality control - adulteration; material review, disposition |
| 15987 | 21 CFR 111.123(b)(3) | Quality control - batch released, adulteration |
| 16040 | 21 CFR 111.610(a) | Records - available; FDA |
| 22717 | 21 CFR 117.130(a)(1) | Hazard analysis - Identification of hazard |
| 3067 | 21 CFR 114.80(a) | Quality control procedures |
| 3075 | 21 CFR 114.80(a)(4) | Container testing |