FDA Inspection 1039294 — VIRTUS PHARMACEUTICALS LLC.
The FDA completed an inspection of VIRTUS PHARMACEUTICALS LLC. on Feb 1, 2018 in Newtown, PA. 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
- Feb 1, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Newtown, PA (United States)
Additional details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 6730 | 21 CFR 314.80(b) | Failure to develop written procedures |
| 6830 | 21 CFR 314.80(c)(2) | Interval |
| 6831 | 21 CFR 314.80(c)(2) | Late submission of quarterly safety reports |
| 6832 | 21 CFR 314.80(c)(2) | Late submission of annual safety reports |