FDA Inspection
Millennium Pharmaceuticals Inc.Millennium Pharmaceuticals Inc. – FDA Inspection, Aug 15, 2014
Record Details
This FDA Inspection record concerns Millennium Pharmaceuticals Inc., with an inspection on August 15, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- August 15, 2014
- Product Type
- Drugs
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ID · de34b7ef-fcdb-4c81-91a4-9cf63fde7ffa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 894268
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 314.81(b)(1)(ii)Contamination, chemical or physical change, deterioration
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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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 |
| 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 |
| December 16, 2011 | VAI | 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 860615 - 2013-12-23
- FDA Inspection 808979 - 2012-11-30
- FDA Inspection 756510 - 2011-12-16
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