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Otsuka Pharmaceutical Co., Ltd.

FDA Regulatory Profile

Otsuka Pharmaceutical Co., Ltd. has 0 FDA recalls, 23 inspections, 6 510(k) clearances and 0 compliance actions on record.

Latest inspection
Oct 10, 2025 · NAI
Latest 510(k)
Mar 9, 2010

Newer recall under related name Otsuka Pharmaceutical Development And Commercialization: Sep 17, 2018, D-0018-2019.

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances6Nov 8, 2026File dated Nov 2, 2026Current
Inspections23Nov 10, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Related names

NameRecalls510(k)InspectionsComplianceMost recent recall
Otsuka Pharmaceutical Development And Commercialization
Same company group		20160Sep 17, 2018 (D-0018-2019)

Recent FDA Inspections

DateSiteProductClassificationFEI
Oct 10, 2025Itano-Gun, JapanDrugsNo Action Indicated (NAI)3003656524
Jul 11, 2025Kanzaki-Gun, JapanDrugsVoluntary Action Indicated (VAI)3003808559
Jun 17, 2025Naka-Gun, JapanDrugsVoluntary Action Indicated (VAI)3004810250
May 16, 2025Tokushima, JapanDrugsNo Action Indicated (NAI)3002809299
Dec 6, 2022Mima, JapanDrugsNo Action Indicated (NAI)3017406106
Oct 22, 2019Naka-Gun, JapanDrugsVoluntary Action Indicated (VAI)3004810250
Oct 10, 2019Tokushima, JapanDrugsNo Action Indicated (NAI)3002809299
Feb 15, 2019Itano-Gun, JapanDrugsVoluntary Action Indicated (VAI)3003656524
Feb 1, 2019Kanzaki-Gun, JapanDrugsVoluntary Action Indicated (VAI)3003808559
Dec 8, 2017Tokushima, JapanDrugsVoluntary Action Indicated (VAI)3002809299
Sep 22, 2016Naka-Gun, JapanDrugsVoluntary Action Indicated (VAI)3004810250
Jul 22, 2016Itano-Gun, JapanDrugsVoluntary Action Indicated (VAI)3003656524
Apr 15, 2016Tokushima, JapanDrugsVoluntary Action Indicated (VAI)3002809299
Apr 8, 2016Kanzaki-Gun, JapanDrugsVoluntary Action Indicated (VAI)3003808559
Dec 5, 2014Kanzaki-Gun, JapanDrugsVoluntary Action Indicated (VAI)3003808559
Sep 18, 2014Tokushima, JapanDrugsVoluntary Action Indicated (VAI)3002809299
Jun 17, 2014Naka-Gun, JapanDrugsVoluntary Action Indicated (VAI)3004810250
Mar 20, 2014Itano-Gun, JapanDrugsVoluntary Action Indicated (VAI)3003656524
Aug 2, 2012Tokushima, JapanDrugsVoluntary Action Indicated (VAI)3002809299
Jul 25, 2012Kanzaki-Gun, JapanDrugsVoluntary Action Indicated (VAI)3003808559

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3003656524Itano-Gun, Japan5Oct 10, 2025
FEI 3003808559Kanzaki-Gun, Japan6Jul 11, 2025
FEI 3004810250Naka-Gun, Japan5Jun 17, 2025
FEI 3002809299Tokushima, Japan6May 16, 2025
FEI 3017406106Mima, Japan1Dec 6, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K092817POC-AS10 AUTO SAMPLERMar 9, 2010
K052716RAPIRUN H. PYLORI ANTIBODY DETECTION KITNov 16, 2006
K041148POCONE INFRARED SPECTROPHOTOMETERJul 15, 2004
K013371UBIT-IR300 INFRARED SPECTROMETRY SYSTEMDec 21, 2001
K001032RLP-CHOLESTEROL IMMUNOSEPARATION ASSAYJul 24, 2000
K991083RLP CHOLESTEROL IMMUNOSEPARATION ASSAYAug 20, 1999

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.