FDA Inspection 998477 — Labomar Canada Inc
The FDA completed an inspection of Labomar Canada Inc on Dec 15, 2016 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 15, 2016
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Pointe-Claire (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 3569 | 21 CFR 211.89 | Quarantine of Rejected Components et. al. |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |