FDA Inspection
Sumitomo Pharma America, Inc.Sumitomo Pharma America, Inc. – FDA Inspection, Dec 9, 2011
Record Details
This FDA Inspection record concerns Sumitomo Pharma America, Inc., with an inspection on December 9, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- December 9, 2011
- Product Type
- Drugs
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ID · 7c1c1c35-c67a-4bf4-a6af-768c1a312d45
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 759431
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 314.81(b)(1)(ii)Contamination, chemical or physical change, deterioration
- 21 CFR 211.192Investigations of discrepancies, failures
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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 |
| January 23, 2015 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| May 24, 2013 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| 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 915063 - 2015-01-23
- FDA Inspection 843011 - 2013-05-24
- FDA Inspection 723394 - 2011-04-20
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