FDA Inspection
Lupin Pharmaceuticals Inc.Lupin Pharmaceuticals Inc. – FDA Inspection, Dec 23, 2011
Record Details
This FDA Inspection record concerns Lupin Pharmaceuticals Inc., with an inspection on December 23, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Lupin Pharmaceuticals Inc.
- Inspection Date
- December 23, 2011
- Product Type
- Drugs
View Company Profile
ID · 9f4dc337-5966-4a49-8108-18311e249ba0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 761230
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 314.81(b)(2)Timely submission
- 21 CFR 314.80(c)(1)(i)Late submission of 15-day report
- 21 CFR 314.80(c)(2)Late submission of quarterly safety reports
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Lupin Pharmaceuticals Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 23, 2014 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| April 6, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 27, 2009 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Lupin Pharmaceuticals Inc.
- FDA Inspection 880292 - 2014-05-23
- FDA Inspection 718224 - 2011-04-06
- FDA Inspection 572735 - 2009-02-27
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.