FDA Inspection
Otsuka Pharmaceutical Development & Commercialization, Inc.Otsuka Pharmaceutical Development & Commercialization, Inc. – FDA Inspection, Mar 18, 2014
Record Details
This FDA Inspection record concerns Otsuka Pharmaceutical Development & Commercialization, Inc., with an inspection on March 18, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- March 18, 2014
- Product Type
- Drugs
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ID · 4ae736dc-c8ef-478e-819a-5439f8e8e120
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 868761
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
2- 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 Otsuka Pharmaceutical Development & Commercialization, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 25, 2025 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 3, 2017 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Otsuka Pharmaceutical Development & Commercialization, Inc.
- FDA Inspection 1276733 - 2025-06-25
- FDA Inspection 1001627 - 2017-02-03
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