FDA Inspection 761230 — Lupin Pharmaceuticals Inc.
The FDA completed an inspection of Lupin Pharmaceuticals Inc. on Dec 23, 2011 in Naples, 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 23, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Naples, FL (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 6732 | 21 CFR 314.80(c)(1)(i) | Late submission of 15-day report |
| 6831 | 21 CFR 314.80(c)(2) | Late submission of quarterly safety reports |
| 8912 | 21 CFR 314.81(b)(2) | Timely submission |