FDA Inspection 1049860 — Badger Botanicals LLC
The FDA completed an inspection of Badger Botanicals LLC on May 9, 2018 in Mapleton, UT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 12 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 9, 2018
- Fiscal Year
- 2018
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Mapleton, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15620 | 21 CFR 111.180(b)(1) | Written procedures - product received |
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15783 | 21 CFR 111.410(d) | Manufacturing history |
| 15785 | 21 CFR 111.410(b) | Label, packaging - discrepancies |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15930 | 21 CFR 111.105 | Quality control - ensure quality; package, labeled, master record |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |
| 16070 | 21 CFR 111.35(b)(2) | Document-equipment date of use, maintain, clean, sanitize |