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868761

Otsuka Pharmaceutical Development & Commercialization, Inc. — FEI 3010447004

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 18, 2014
Fiscal Year
2014
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Princeton, NJ (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Facility

Other inspections at this facility

  • 1276733 (NAI Wed Jun 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1001627 (NAI Fri Feb 03 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
673221 CFR 314.80(c)(1)(i)Late submission of 15-day report
673621 CFR 314.80(c)(1)(ii)Submission of report follow-up