FDA Inspection 1033914 — Les Importations Herbasante Inc.
The FDA completed an inspection of Les Importations Herbasante Inc. on Dec 1, 2017 in Saint-Laurent. 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 1, 2017
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Saint-Laurent (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1163 | 21 CFR 211.28(b) | Habits of good sanitation & health |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1722 | 21 CFR 211.134(a) | Correct labels during finishing operations |
| 2024 | 21 CFR 211.188(b)(12) | Documentation of Batch Investigations |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |