FDA Inspection 1151089 — Origin Nutraceutical Inc.
The FDA completed an inspection of Origin Nutraceutical Inc. on September 7, 2021 in Spanish Fork, UT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 7, 2021
- Fiscal Year
- 2021
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Spanish Fork, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15543 | 21 CFR 111.260(c) | Batch record - date, time; maintenance |
| 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 |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |
| 15938 | 21 CFR 111.105(f) | Quality control - representative samples |
| 15975 | 21 CFR 111.120(e) | Quality control operations - quarantine |
| 15977 | 21 CFR 111.123(a)(1) | Quality control operations - master manufacturing record, modifications |
| 15983 | 21 CFR 111.123(a)(7) | Quality control operations - finished batch, specifications |