FDA Inspection
Sumitomo Pharma America, Inc.Sumitomo Pharma America, Inc. – FDA Inspection, Jan 23, 2015
Record Details
This FDA Inspection record concerns Sumitomo Pharma America, Inc., with an inspection on January 23, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- January 23, 2015
- Product Type
- Drugs
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ID · d108866d-e164-4636-94bd-c5c66405a7b5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 915063
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
1- 21 CFR 314.80(c)(1)(i)Late submission of 15-day report
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Other FDA inspections of Sumitomo Pharma America, Inc.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| August 2, 2024 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| November 5, 2021 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| May 24, 2013 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| December 9, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 20, 2011 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Sumitomo Pharma America, Inc.
- FDA Inspection 1242239 - 2024-08-02
- FDA Inspection 1161579 - 2021-11-05
- FDA Inspection 843011 - 2013-05-24
- FDA Inspection 759431 - 2011-12-09
- FDA Inspection 723394 - 2011-04-20
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