FDA Inspection 1108324 — New Dawn Nutrition, Inc.
The FDA completed an inspection of New Dawn Nutrition, Inc. on Nov 1, 2019 in Omaha, NE. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Nov 1, 2019
- Fiscal Year
- 2020
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Omaha, NE (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15610 | 21 CFR 111.165(d)(1) | Product received - identify |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15786 | 21 CFR 111.410(b) | Labels - issuance, use |
| 15790 | 21 CFR 111.403 | Written procedures - labeling operations |
| 15841 | 21 CFR 111.70(f) | Specifications - product received for packaging, labeling |
| 15928 | 21 CFR 111.103 | Written procedure quality control operations material review |