FDA Inspection 1062610 — Horizon Pharmaceuticals, Inc.
The FDA completed an inspection of Horizon Pharmaceuticals, Inc. on August 17, 2018 in Riviera Beach, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 17, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Riviera Beach, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1384 | 21 CFR 211.101(c) | Weighing/measuring/subdividing supervision |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 3588 | 21 CFR 211.110(a)(3) | Mixing adequacy |