FDA Inspection 1167415 — Nature's Rite, LLC
The FDA completed an inspection of Nature's Rite, LLC on April 8, 2022 in Sarasota, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 8, 2022
- Fiscal Year
- 2022
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Sarasota, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15404 | 21 CFR 111.12(c) | Personnel - education, training, experience |
| 15748 | 21 CFR 111.210(f) | Master manufacturing record theoretical and expected yield |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15933 | 21 CFR 111.105(b) | Quality control - supplier qualification |
| 15983 | 21 CFR 111.123(a)(7) | Quality control operations - finished batch, specifications |
| 16014 | 21 CFR 111.140(b)(1) | QC ops; written procedures; material review, disposition |