FDA Inspection 1014432 — Ross Healthcare Inc.
The FDA completed an inspection of Ross Healthcare Inc. on June 16, 2017 in Delta. 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
- June 16, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Delta (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 2005 | 21 CFR 211.184(e) | Records of disposition of rejected material |
| 2567 | 21 CFR 211.198(a) | Adverse Drug Experience |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4366 | 21 CFR 211.188(a) | Accurate reproduction included |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |