FDA Inspection 765438 — Cellex-C International
The FDA completed an inspection of Cellex-C International on Jan 17, 2012 in Toronto. 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
- Jan 17, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Toronto (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 4351 | 21 CFR 211.160(b)(3) | Drug products - samples representative, identified properly |