FDA Inspection 1279890 — 2629168 Ontario Inc.
The FDA completed an inspection of 2629168 Ontario Inc. on August 28, 2025 in Windsor. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 15 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 28, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Windsor (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 15447 | 21 CFR 111.15(c)(3) | Cleaning compounds and toxic materials - holding |
| 15496 | 21 CFR 111.27(b) | Instruments - calibration |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15533 | 21 CFR 111.255(c) | Batch record - follow master |
| 15646 | 21 CFR 111.460(a) | Hold, identify - in-process material |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 22812 | 21 CFR 111.453 | Written procedures - follow; holding and distribution |
| 22816 | 21 CFR 111.8 | Written procedures - follow; personnel |
| 22821 | 21 CFR 111.14(b)(1) | Personnel - records - written procedures and training |
| 22828 | 21 CFR 111.16 | Written procedures - follow; cleaning |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22854 | 21 CFR 111.83(b) | Reserve sample - container-closure system |
| 22860 | 21 CFR 111.103 | Written procedures - follow; quality control operations |
| 22884 | 21 CFR 111.205(a) | Master manufacturing record - prepared |