FDA Inspection 1113009 — Monfitello Inc.
The FDA completed an inspection of Monfitello Inc. on December 17, 2019 in Lachine. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 17, 2019
- Fiscal Year
- 2020
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Lachine (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 3078 | 21 CFR 114.80(b) | Code - required elements |
| 4470 | 21 CFR 108.25(c)(2) | Process filing |
| 4511 | 21 CFR 108.25(f) | Approved school |