1178342
RegenX, LLC — FEI 3011124037
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 24, 2022
- Fiscal Year
- 2022
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Bloomer, WI (United States)
Citations
| ID | CFR | Description |
|---|
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15772 | 21 CFR 111.415(g) | Representative sample - packaged, labeled dietary supplement |
| 15774 | 21 CFR 111.415(f)(1) | Batch-lot,control number packaged, labeled dietary supplemen |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 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 |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 15944 | 21 CFR 111.105(i) | QC - required operations master manufacturing/batch records |
| 16068 | 21 CFR 111.35(b)(1)(iii) | Equipment, utensils; maintaining, cleaning, sanitizing |