FDA Inspection 1319056 — Noven Pharmaceuticals, Inc.
The FDA completed an inspection of Noven Pharmaceuticals, Inc. on Aug 24, 2026 in Miami, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 24, 2026
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1256 | 21 CFR 211.68(b) | Backup file not maintained |
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |