FDA Inspection 849450 — Les Importations Herbasante Inc.
The FDA completed an inspection of Les Importations Herbasante Inc. on Aug 23, 2013 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). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 23, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Saint-Laurent (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 1928 | 21 CFR 211.166(c)(1) | Homeopathic drugs, assessment of stability |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4315 | 21 CFR 211.84(d)(2) | Testing Each Component for Conformity with Specs |