FDA Inspection 983076 — Cedar Bear Naturales Inc.
The FDA completed an inspection of Cedar Bear Naturales Inc. on August 4, 2016 in Roosevelt, UT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 4, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Roosevelt, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15492 | 21 CFR 111.25(a) | Procedures - calibrating instruments |
| 15557 | 21 CFR 111.260(k) | Batch record - packaging, labeling |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15840 | 21 CFR 111.70(e) | Specifications - contamination limits |
| 15843 | 21 CFR 111.70(g) | Specifications - finished packaging, labeling |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15875 | 21 CFR 111.75(d)(1) | Documentation specifications met; exempted, periodic testing |