Otsuka Pharmaceutical Co. Ltd., Tokushima, Japan – FDA Inspections

Inspection records and compliance data for Otsuka Pharmaceutical Co. Ltd. in Tokushima. 6 FDA inspections on record, 1 Form 483, last inspected May 16, 2025.

Company Profile

This profile covers Otsuka Pharmaceutical Co. Ltd. based in Tokushima, Japan.

FDA Inspection History

FDA inspections: 6
OAI: 0
VAI: 4
NAI: 2
Form 483s: 1
Warning letters: 0

First inspected August 2, 2012. Last inspected May 16, 2025.

Most cited issue areas

Procedures for non-sterile drug products1 inspection
Procedures not in writing, fully followed1 inspection
Written procedures fail to include1 inspection

FDA inspections (6)

Date	Result	FDA center(s)	Insp. #
May 16, 2025	NAI	Human Drugs · Drug Quality Assurance	1274284
October 10, 2019	NAI	Human Drugs · Drug Quality Assurance	1112200
December 8, 2017	VAI	Human Drugs · Drug Quality Assurance	1037241
April 15, 2016	VAI	Human Drugs · Drug Quality Assurance	969641
September 18, 2014	VAI	Human Drugs · Drug Quality Assurance	899637
August 2, 2012	VAI	Human Drugs · Drug Quality Assurance	796785

FDA documents

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

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