FDA Inspection 1118211 — Atsenti Inc.
The FDA completed an inspection of Atsenti Inc. on Feb 3, 2020 in Saint-Hyacinthe. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 3, 2020
- Fiscal Year
- 2020
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Saint-Hyacinthe (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 15542 | 21 CFR 111.260(b) | Batch record - date, time; maintenance |
| 15543 | 21 CFR 111.260(c) | Batch record - date, time; maintenance |
| 15566 | 21 CFR 111.260(l)(3) | Batch record - approved, released, rejected; batch |
| 15737 | 21 CFR 111.210(h)(5) | Corrective action plans |
| 15744 | 21 CFR 111.210(h)(2) | Master manufacturing record - sampling, tests, examinations |