1230783
Boxley Botanicals LLC — FEI 3013353907
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 4, 2024
- Fiscal Year
- 2024
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Cub Run, KY (United States)
Citations
| ID | CFR | Description |
|---|
| 15542 | 21 CFR 111.260(b) | Batch record - date, time; maintenance |
| 15543 | 21 CFR 111.260(c) | Batch record - date, time; maintenance |
| 15567 | 21 CFR 111.260(l)(4) | Batch record - approved, released, rejected |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15831 | 21 CFR 111.70(b)(3) | Specifications - contamination limits |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15840 | 21 CFR 111.70(e) | Specifications - contamination limits |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15921 | 21 CFR 111.95(b)(2) | Documentation - supplier qualification |
| 15928 | 21 CFR 111.103 | Written procedure quality control operations material review |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |
| 15977 | 21 CFR 111.123(a)(1) | Quality control operations - master manufacturing record, modifications |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |
| 16071 | 21 CFR 111.35(b)(3) | Documentation - instruments, controls; calibrations |