FDA Inspection 1148122 — New Dawn Nutrition, Inc.
The FDA completed an inspection of New Dawn Nutrition, Inc. on August 6, 2021 in Omaha, NE. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 6, 2021
- Fiscal Year
- 2021
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Omaha, NE (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15560 | 21 CFR 111.260(k)(2) | Batch record - label |
| 15573 | 21 CFR 111.153 | Written procedures - product received; packaging, labeling |
| 15619 | 21 CFR 111.180(b)(1) | Written procedures - packaging, labeling received |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15786 | 21 CFR 111.410(b) | Labels - issuance, use |
| 15790 | 21 CFR 111.403 | Written procedures - labeling operations |
| 15828 | 21 CFR 111.70(a) | Specifications - manufacturing process |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 15928 | 21 CFR 111.103 | Written procedure quality control operations material review |