Company
United StatesOtsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ – FDA Inspections
Inspection records and compliance data for Otsuka Pharmaceutical Development & Commercialization, Inc. in Princeton, New Jersey. 3 FDA inspections on record, last inspected June 25, 2025.
Company Profile
This profile covers Otsuka Pharmaceutical Development & Commercialization, Inc. based in Princeton, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected March 18, 2014. Last inspected June 25, 2025.
Most cited issue areas
- Late submission of 15-day report1 inspection
- Submission of report follow-up1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 25, 2025 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1276733 |
| February 3, 2017 | NAI | Human Drugs · Bioresearch Monitoring | 1001627 |
| March 18, 2014 | VAI | Human Drugs · Bioresearch Monitoring | 868761 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Otsuka Pharmaceutical Development & Commercialization, Inc.
FEI Number
3010447004
Address
508 Carnegie Ctr, Princeton, New Jersey 08540, United States
Country
United States
ID: a1427d0e-e216-46ba-9158-bc52701a7a70