FDA Inspection 1097815 — New Spirit Naturals Inc.
The FDA completed an inspection of New Spirit Naturals Inc. on July 26, 2019 in San Dimas, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 26, 2019
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- San Dimas, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15496 | 21 CFR 111.27(b) | Instruments - calibration |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15760 | 21 CFR 111.205(b)(1) | Master manufacturing record-specifications; packaged, label |
| 15831 | 21 CFR 111.70(b)(3) | Specifications - contamination limits |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15862 | 21 CFR 111.75(a)(2) | Appropriate tests, examinations; certificate of analysis |
| 15931 | 21 CFR 111.105 | Quality control - packaged, labeled |
| 15963 | 21 CFR 111.113(b)(2) | Quality control - reject; specification not met |
| 9936 | 21 CFR 120.7(a) | Hazard analysis - written - elements |
| 9961 | 21 CFR 120.24(a) | Process controls - HACCP plan - 5 log reduction |