FDA Inspection 723150 — Botanic Innovations, LLC
The FDA completed an inspection of Botanic Innovations, LLC on Apr 28, 2011 in Spooner, WI. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 13 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Apr 28, 2011
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Spooner, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15458 | 21 CFR 111.20(d)(1)(i) | Floors, walls, ceilings |
| 15505 | 21 CFR 111.27(a)(3)(v) | Equipment - protect from contamination |
| 15683 | 21 CFR 111.315(c) | Examination, testing methods; criteria for selecting |
| 15698 | 21 CFR 111.320(a) | Examination, testing; appropriate |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15796 | 21 CFR 111.430(b) | Records - packaging, labeling operations |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15828 | 21 CFR 111.70(a) | Specifications - manufacturing process |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15875 | 21 CFR 111.75(d)(1) | Documentation specifications met; exempted, periodic testing |
| 15976 | 21 CFR 111.123 | Quality control operations - master, batch, manufacturing |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |