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01 13Otsuka America Pharmaceutical, Inc.

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PharmaCompass

01

FDA Audited

USA
euroPLX 86 Munich
Not Confirmed
arrow

FDA Audited

USA
arrow
euroPLX 86 Munich
Not Confirmed

Otsuka America Pharmaceutical, Inc.

City : Rockville

State : MD

Country/Area : US

Zip : 20850-3238

District : BLT

Center : CDRH

Project Area : Postmarket Assurance: Devices

District Decision : No Action Indicated

Inspection End Date : 2013-02-25

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02

FDA Audited

USA
euroPLX 86 Munich
Not Confirmed
arrow

FDA Audited

USA
arrow
euroPLX 86 Munich
Not Confirmed

Otsuka America Pharmaceutical, Inc.

City : Rockville

State : MD

Country/Area : US

Zip : 20850-3238

District : BLT

Center : CDRH

Project Area : Project Evaluation: Devices

District Decision : No Action Indicated

Inspection End Date : 2013-02-25

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03

FDA Audited

USA
euroPLX 86 Munich
Not Confirmed
arrow

FDA Audited

USA
arrow
euroPLX 86 Munich
Not Confirmed

Otsuka America Pharmaceutical, Inc.

City : Rockville

State : MD

Country/Area : US

Zip : 20850-3238

District : BLT

Center : CDRH

Project Area : Compliance: Devices

District Decision : Voluntary Action Indicated

Inspection End Date : 2014-09-26

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04

FDA Audited

USA
euroPLX 86 Munich
Not Confirmed
arrow

FDA Audited

USA
arrow
euroPLX 86 Munich
Not Confirmed

Otsuka America Pharmaceutical, Inc.

City : Rockville

State : MD

Country/Area : US

Zip : 20850-3238

District : BLT

Center : CDRH

Project Area : Postmarket Assurance: Devices

District Decision : Voluntary Action Indicated

Inspection End Date : 2014-09-26

blank

05

FDA Audited

USA
euroPLX 86 Munich
Not Confirmed
arrow

FDA Audited

USA
arrow
euroPLX 86 Munich
Not Confirmed

Otsuka America Pharmaceutical, Inc.

City : Rockville

State : MD

Country/Area : US

Zip : 20850-3238

District : BLT

Center : CDER

Project Area : Bioresearch Monitoring

District Decision : No Action Indicated

Inspection End Date : 2014-11-19

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06

FDA Audited

USA
euroPLX 86 Munich
Not Confirmed
arrow

FDA Audited

USA
arrow
euroPLX 86 Munich
Not Confirmed

Otsuka America Pharmaceutical, Inc.

City : Rockville

State : MD

Country/Area : US

Zip : 20850-3238

District : BLT

Center : CDRH

Project Area : Compliance: Devices

District Decision : No Action Indicated

Inspection End Date : 2015-05-06

blank

07

FDA Audited

USA
euroPLX 86 Munich
Not Confirmed
arrow

FDA Audited

USA
arrow
euroPLX 86 Munich
Not Confirmed

Otsuka America Pharmaceutical, Inc.

City : Rockville

State : MD

Country/Area : US

Zip : 20850-3238

District : BLT

Center : CDRH

Project Area : Compliance: Devices

District Decision : Voluntary Action Indicated

Inspection End Date : 2009-04-14

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08

FDA Audited

USA
euroPLX 86 Munich
Not Confirmed
arrow

FDA Audited

USA
arrow
euroPLX 86 Munich
Not Confirmed

Otsuka America Pharmaceutical, Inc.

City : Rockville

State : MD

Country/Area : US

Zip : 20850-3238

District : BLT

Center : CDRH

Project Area : Project Evaluation: Devices

District Decision : Voluntary Action Indicated

Inspection End Date : 2010-10-27

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09

FDA Audited

USA
euroPLX 86 Munich
Not Confirmed
arrow

FDA Audited

USA
arrow
euroPLX 86 Munich
Not Confirmed

Otsuka America Pharmaceutical, Inc.

City : Rockville

State : MD

Country/Area : US

Zip : 20850-3238

District : BLT

Center : CDER

Project Area : Postmarket Surv. and Epidemiolog...

District Decision : Voluntary Action Indicated

Inspection End Date : 2012-07-20

blank

10

FDA Audited

USA
euroPLX 86 Munich
Not Confirmed
arrow

FDA Audited

USA
arrow
euroPLX 86 Munich
Not Confirmed

Otsuka America Pharmaceutical, Inc.

City : Rockville

State : MD

Country/Area : US

Zip : 20850-3238

District : BLT

Center : CDER

Project Area : Postmarket Surv. and Epidemiolog...

District Decision : No Action Indicated

Inspection End Date : 2012-07-20

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