FDA Inspection 1190724 — Botanic Tonics, LLC
The FDA completed an inspection of Botanic Tonics, LLC on November 17, 2022 in Broken Arrow, OK. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 12 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 17, 2022
- Fiscal Year
- 2023
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Broken Arrow, OK (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15533 | 21 CFR 111.255(c) | Batch record - follow master |
| 15570 | 21 CFR 111.153 | Written procedures - components |
| 15673 | 21 CFR 111.315(a) | Criteria for establishing specifications |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15821 | 21 CFR 111.60(a) | Production, in- process control system - design, quality |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15983 | 21 CFR 111.123(a)(7) | Quality control operations - finished batch, specifications |
| 3072 | 21 CFR 114.80(a)(1) | Thermal processing |
| 3085 | 21 CFR 114.100(a) | Raw materials, packaging, finished product |
| 3090 | 21 CFR 114.100(d) | Product distribution |
| 4464 | 21 CFR 108.25(c)(1) | Registration |