FDA Inspection
Otsuka Pharmaceutical Development & Commercialization, IncOtsuka Pharmaceutical Development & Commercialization, Inc – FDA Inspection, Sep 26, 2014
Record Details
This FDA Inspection record concerns Otsuka Pharmaceutical Development & Commercialization, Inc, with an inspection on September 26, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 26, 2014
- Product Type
- Devices
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ID · d6a8e15d-0c68-47bd-8c28-1f755c3f0fff
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 897654
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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Other FDA inspections of Otsuka Pharmaceutical Development & Commercialization, Inc
12| Date | Classification | Office | Project area |
|---|---|---|---|
| July 18, 2025 | Not classified | Baltimore District Office | |
| September 7, 2023 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| February 27, 2023 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| November 14, 2018 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| May 19, 2017 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Otsuka Pharmaceutical Development & Commercialization, Inc
- FDA Inspection 1273580 - 2025-07-18
- FDA Inspection 1219094 - 2023-09-07
- FDA Inspection 1199647 - 2023-02-27
- FDA Inspection 1074034 - 2018-11-14
- FDA Inspection 1012315 - 2017-05-19
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