FDA Inspection 1113218 — Immunotec Fabrication
The FDA completed an inspection of Immunotec Fabrication on December 19, 2019 in Blainville. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 19, 2019
- Fiscal Year
- 2020
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Blainville (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1473 | 21 CFR 113.83 | Scheduled process - scientific methods not used |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 4524 | 21 CFR 108.35(g) | Approved school |