FDA Inspection 605450 — Labomar Canada Inc
The FDA completed an inspection of Labomar Canada Inc on Aug 13, 2009 in Pointe-Claire. 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 13, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Pointe-Claire (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1630 | 21 CFR 211.130(b) | Unlabeled filled containers controls |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1976 | 21 CFR 211.182 | Specific information required in individual logs |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |