FDA Inspection 1112169 — C R Supplements LLC
The FDA completed an inspection of C R Supplements LLC on December 4, 2019 in Kooskia, ID. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 15 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- December 4, 2019
- Fiscal Year
- 2020
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Kooskia, ID (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15381 | 21 CFR 111.8 | Written procedures - hygienic practices |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15570 | 21 CFR 111.153 | Written procedures - components |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15790 | 21 CFR 111.403 | Written procedures - labeling operations |
| 15791 | 21 CFR 111.403 | Written procedures -packaging operations |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 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 |
| 15928 | 21 CFR 111.103 | Written procedure quality control operations material review |
| 16068 | 21 CFR 111.35(b)(1)(iii) | Equipment, utensils; maintaining, cleaning, sanitizing |