FDA Inspection 958746 — CreAgri, Inc.
The FDA completed an inspection of CreAgri, Inc. on December 18, 2015 in Newark, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 18, 2015
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Newark, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15687 | 21 CFR 111.315(b)(4) | Sampling plans; product for packaging, labeling |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15952 | 21 CFR 111.113 | Quality control operations - material review, disposition |