FDA Inspection 1102798 — 8046255 Canada Inc. DBA Viatrexx
The FDA completed an inspection of 8046255 Canada Inc. DBA Viatrexx on September 24, 2019 in Beloeil. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 24, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Beloeil (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1159 | 21 CFR 211.28(a) | Clothing appropriate for duties performed |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |