947268
Horizon Pharmaceuticals, Inc. — FEI 3000718824
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 5, 2015
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Riviera Beach, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1409 | 21 CFR 211.42(c)(4) | In-Process Material Area |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |