FDA Inspection 1094507 — Cedar Bear Naturales Inc.
The FDA completed an inspection of Cedar Bear Naturales Inc. on June 28, 2019 in Roosevelt, UT. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 12 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 28, 2019
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Roosevelt, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15482 | 21 CFR 111.23(c) | Records - water |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15557 | 21 CFR 111.260(k) | Batch record - packaging, labeling |
| 15748 | 21 CFR 111.210(f) | Master manufacturing record theoretical and expected yield |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15870 | 21 CFR 111.75(c)(1) | Specifications met - verify; production, process control |
| 15921 | 21 CFR 111.95(b)(2) | Documentation - supplier qualification |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |
| 15951 | 21 CFR 111.110(c) | Quality control operations - tests, examinations; results |
| 16070 | 21 CFR 111.35(b)(2) | Document-equipment date of use, maintain, clean, sanitize |