FDA Inspection 1046876 — Avalon Packaging, Inc.
The FDA completed an inspection of Avalon Packaging, Inc. on March 26, 2018 in Orem, UT. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 26, 2018
- Fiscal Year
- 2018
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Orem, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15511 | 21 CFR 111.27(d) | Equipment - maintain - general |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15760 | 21 CFR 111.205(b)(1) | Master manufacturing record-specifications; packaged, label |
| 15786 | 21 CFR 111.410(b) | Labels - issuance, use |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15831 | 21 CFR 111.70(b)(3) | Specifications - contamination limits |
| 15832 | 21 CFR 111.70(c)(1) | In-process identity, purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 16037 | 21 CFR 111.605 | Records - keep: 1 year, 2 years |