FDA Inspection 1109650 — Validus Pharmaceuticals, Inc.
The FDA completed an inspection of Validus Pharmaceuticals, Inc. on November 13, 2019 in Parsippany, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 13, 2019
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Parsippany, NJ (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 6830 | 21 CFR 314.80(c)(2) | Interval |
| 6835 | 21 CFR 314.80(d) | Failure to submit scientific article |
| 8912 | 21 CFR 314.81(b)(2) | Timely submission |