Otsuka America Pharmaceutical, Inc. | FDA | Inspections | Form 483 | Warning Letters | PharmaCompass.com

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Otsuka America Pharmaceutical, Inc.
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Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.

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Kikkoman Biochemifa Company advances global health and safety through precision-driven innovation in biotech and food testing.

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Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

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Otsuka America Pharmaceutical, Inc.

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Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow, 33 News #PharmaBuzz

Interview #SpeakPharma
Vlog #PharmaReel
Data Compilation #PharmaFlow
33 News #PharmaBuzz

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2 FDF Dossiers, 2 FDA Orange Book

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INSPECTIONS & REGISTRATIONS

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filter Legal Name Reset all filters

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01 13Otsuka America Pharmaceutical, Inc.

filter District Decision Reset all filters

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01 6No Action Indicated

02 7Voluntary Action Indicated

filter Inspection End Date Reset all filters

13 All

01 22017-05-19

02 22015-05-06

03 12014-11-19

04 22014-09-26

05 22013-02-25

06 22012-07-20

07 12010-10-27

08 12009-04-14

filter City Reset all filters

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01 13Rockville

filter Country/Area Reset all filters

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01 13U.S.A

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01

FDA Audited

USA

AIChE Annual Meeting

Not Confirmed

FDA Audited

USA

AIChE Annual Meeting

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

District Decision : Voluntary Action Indicated

Inspection End Date : 2017-05-19

Otsuka America Pharmaceutical, Inc.

City : Rockville

State : MD

Country/Area : U.S.A

Zip : 20850-3238

District : BLT

Center : CDRH

Project Area : Compliance: Devices

District Decision : Voluntary Action Indicated

Inspection End Date : 2017-05-19

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

02

FDA Audited

USA

AIChE Annual Meeting

Not Confirmed

FDA Audited

USA

AIChE Annual Meeting

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

District Decision : Voluntary Action Indicated

Inspection End Date : 2017-05-19

Otsuka America Pharmaceutical, Inc.

City : Rockville

State : MD

Country/Area : U.S.A

Zip : 20850-3238

District : BLT

Center : CDRH

Project Area : Postmarket Assurance: Devices

District Decision : Voluntary Action Indicated

Inspection End Date : 2017-05-19

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

03

FDA Audited

USA

AIChE Annual Meeting

Not Confirmed

FDA Audited

USA

AIChE Annual Meeting

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

District Decision : No Action Indicated

Inspection End Date : 2015-05-06

Otsuka America Pharmaceutical, Inc.

City : Rockville

State : MD

Country/Area : U.S.A

Zip : 20850-3238

District : BLT

Center : CDRH

Project Area : Compliance: Devices

District Decision : No Action Indicated

Inspection End Date : 2015-05-06

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

04

FDA Audited

USA

AIChE Annual Meeting

Not Confirmed

FDA Audited

USA

AIChE Annual Meeting

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

District Decision : No Action Indicated

Inspection End Date : 2015-05-06

Otsuka America Pharmaceutical, Inc.

City : Rockville

State : MD

Country/Area : U.S.A

Zip : 20850-3238

District : BLT

Center : CDRH

Project Area : Postmarket Assurance: Devices

District Decision : No Action Indicated

Inspection End Date : 2015-05-06

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

05

FDA Audited

USA

AIChE Annual Meeting

Not Confirmed

FDA Audited

USA

AIChE Annual Meeting

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

District Decision : No Action Indicated

Inspection End Date : 2014-11-19

Otsuka America Pharmaceutical, Inc.

City : Rockville

State : MD

Country/Area : U.S.A

Zip : 20850-3238

District : BLT

Center : CDER

Project Area : Bioresearch Monitoring

District Decision : No Action Indicated

Inspection End Date : 2014-11-19

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

06

FDA Audited

USA

AIChE Annual Meeting

Not Confirmed

FDA Audited

USA

AIChE Annual Meeting

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

District Decision : Voluntary Action Indicated

Inspection End Date : 2014-09-26

Otsuka America Pharmaceutical, Inc.

City : Rockville

State : MD

Country/Area : U.S.A

Zip : 20850-3238

District : BLT

Center : CDRH

Project Area : Postmarket Assurance: Devices

District Decision : Voluntary Action Indicated

Inspection End Date : 2014-09-26

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

07

FDA Audited

USA

AIChE Annual Meeting

Not Confirmed

FDA Audited

USA

AIChE Annual Meeting

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

District Decision : Voluntary Action Indicated

Inspection End Date : 2014-09-26

Otsuka America Pharmaceutical, Inc.

City : Rockville

State : MD

Country/Area : U.S.A

Zip : 20850-3238

District : BLT

Center : CDRH

Project Area : Compliance: Devices

District Decision : Voluntary Action Indicated

Inspection End Date : 2014-09-26

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

08

FDA Audited

USA

AIChE Annual Meeting

Not Confirmed

FDA Audited

USA

AIChE Annual Meeting

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

District Decision : No Action Indicated

Inspection End Date : 2013-02-25

Otsuka America Pharmaceutical, Inc.

City : Rockville

State : MD

Country/Area : U.S.A

Zip : 20850-3238

District : BLT

Center : CDRH

Project Area : Postmarket Assurance: Devices

District Decision : No Action Indicated

Inspection End Date : 2013-02-25

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

09

FDA Audited

USA

AIChE Annual Meeting

Not Confirmed

FDA Audited

USA

AIChE Annual Meeting

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

District Decision : No Action Indicated

Inspection End Date : 2013-02-25

Otsuka America Pharmaceutical, Inc.

City : Rockville

State : MD

Country/Area : U.S.A

Zip : 20850-3238

District : BLT

Center : CDRH

Project Area : Project Evaluation: Devices

District Decision : No Action Indicated

Inspection End Date : 2013-02-25

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

10

FDA Audited

USA

AIChE Annual Meeting

Not Confirmed

FDA Audited

USA

AIChE Annual Meeting

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

District Decision : Voluntary Action Indicated

Inspection End Date : 2012-07-20

Otsuka America Pharmaceutical, Inc.

City : Rockville

State : MD

Country/Area : U.S.A

Zip : 20850-3238

District : BLT

Center : CDER

Project Area : Postmarket Surv. and Epidemiolog...

District Decision : Voluntary Action Indicated

Inspection End Date : 2012-07-20

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

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