FDA Inspection 1215209 — Les Importations Herbasante Inc.
The FDA completed an inspection of Les Importations Herbasante Inc. on Aug 18, 2023 in Saint-Laurent. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 6 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Aug 18, 2023
- Fiscal Year
- 2023
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Saint-Laurent (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1843 | 21 CFR 211.84(d)(2) | Component written specification |
| 1851 | 21 CFR 211.84(e) | Rejecting When Specifications Not Met |