FDA Inspection 546845 — Sigma-Tau Pharmaceuticals, Inc.
The FDA completed an inspection of Sigma-Tau Pharmaceuticals, Inc. on Oct 16, 2008 in Gaithersburg, MD. 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 16, 2008
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Gaithersburg, MD (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 6832 | 21 CFR 314.80(c)(2) | Late submission of annual safety reports |
| 8912 | 21 CFR 314.81(b)(2) | Timely submission |