FDA Inspection
Takeda Pharmaceuticals USA, Inc.Takeda Pharmaceuticals USA, Inc. – FDA Inspection, Sep 9, 2016
Record Details
This FDA Inspection record concerns Takeda Pharmaceuticals USA, Inc., with an inspection on September 9, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 9, 2016
- Product Type
- Drugs
View Company Profile
ID · 79ce5fb5-95a6-43f1-b5a1-8073b2a5b82a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 988237
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
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
Full citation text and observation details available on the Dashboard.
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 |
| January 28, 2013 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| January 18, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| 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 818340 - 2013-01-28
- FDA Inspection 811093 - 2013-01-18
- FDA Inspection 756349 - 2011-12-08
- FDA Inspection 662088 - 2010-04-27
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.