Otsuka Pharmaceutical Co., Ltd., Itano-Gun, Japan – FDA Inspections

Inspection records and compliance data for Otsuka Pharmaceutical Co., Ltd. in Itano-Gun. 5 FDA inspections on record, 1 Form 483, last inspected October 10, 2025.

Company Profile

This profile covers Otsuka Pharmaceutical Co., Ltd. based in Itano-Gun, Japan.

FDA Inspection History

FDA inspections: 5
OAI: 0
VAI: 4
NAI: 0
Unclassified: 1
Form 483s: 1
Warning letters: 0

First inspected October 21, 2011. Last inspected October 10, 2025.

Most cited issue areas

Cleaning / Sanitizing / Maintenance2 inspections
Written procedures not established/followed2 inspections
Absence of Written Procedures1 inspection

FDA inspections (5)

Date	Result	FDA center(s)	Insp. #
October 10, 2025	Not classified	Human Drugs	1291346
February 15, 2019	VAI	Human Drugs · Drug Quality Assurance	1079491
July 22, 2016	VAI	Human Drugs · Drug Quality Assurance	980250
March 20, 2014	VAI	Human Drugs · Drug Quality Assurance	873409
October 21, 2011	VAI	Human Drugs · Drug Quality Assurance	754803

FDA documents

No Form 483s, Warning Letters or EIRs on record.

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