FDA Inspection
Takeda Pharmaceuticals USA, Inc.Takeda Pharmaceuticals USA, Inc. – FDA Inspection, Jan 18, 2013
Record Details
This FDA Inspection record concerns Takeda Pharmaceuticals USA, Inc., with an inspection on January 18, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- January 18, 2013
- Product Type
- Drugs
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ID · 9a2e2493-95a8-4426-a28d-f249cb9a6c6d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 811093
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 314.80(b)Failure to review ADE information
- 21 CFR 314.80(c)(1)(ii)Submission of report follow-up
- 21 CFR 314.80(c)(1)(i)Late submission of 15-day report
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Other FDA inspections of Takeda Pharmaceuticals USA, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 25, 2019 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| September 9, 2016 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| January 28, 2013 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| December 8, 2011 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| April 27, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Takeda Pharmaceuticals USA, Inc.
- FDA Inspection 1107731 - 2019-10-25
- FDA Inspection 988237 - 2016-09-09
- FDA Inspection 818340 - 2013-01-28
- FDA Inspection 756349 - 2011-12-08
- FDA Inspection 662088 - 2010-04-27
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