Otsuka America Pharmaceutical, Inc.

FDA Regulatory Profile

Otsuka America Pharmaceutical, Inc. appears in FDA public data with 0 recalls, 3 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on June 30, 2025.

Summary

Total Recalls
0
510(k) Clearances
3
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K251088Otsuka Digital Feedback DeviceJune 30, 2025
K231209RejoynMarch 30, 2024
K223463Otsuka Digital Feedback Device-RWAugust 11, 2023