FDA Inspection
Millennium Pharmaceuticals Inc.Millennium Pharmaceuticals Inc. – FDA Inspection, Dec 16, 2011
Record Details
This FDA Inspection record concerns Millennium Pharmaceuticals Inc., with an inspection on December 16, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- December 16, 2011
- Product Type
- Drugs
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ID · 26c2face-15e9-4bd5-8c75-11018948ea82
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 756510
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.110(a)Written in-process control procedures
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Other FDA inspections of Millennium Pharmaceuticals Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| April 13, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 21, 2015 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| August 15, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 23, 2013 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| November 30, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Millennium Pharmaceuticals Inc.
- FDA Inspection 971665 - 2016-04-13
- FDA Inspection 948448 - 2015-10-21
- FDA Inspection 894268 - 2014-08-15
- FDA Inspection 860615 - 2013-12-23
- FDA Inspection 808979 - 2012-11-30
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