FDA Inspection 906972 — Stratus Pharmaceuticals Inc
The FDA completed an inspection of Stratus Pharmaceuticals Inc on December 8, 2014 in Miami, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 8, 2014
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 2567 | 21 CFR 211.198(a) | Adverse Drug Experience |
| 4388 | 21 CFR 211.198(a) | Complaints reviewed by Quality Control Unit |