01 13Otsuka America Pharmaceutical, Inc.
01 6No Action Indicated
02 7Voluntary Action Indicated
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
01 13Rockville
01 13US
District Decision : No Action Indicated
Inspection End Date : 2013-02-25
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
District Decision : No Action Indicated
Inspection End Date : 2013-02-25
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
District Decision : Voluntary Action Indicated
Inspection End Date : 2014-09-26
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
District Decision : Voluntary Action Indicated
Inspection End Date : 2014-09-26
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
District Decision : No Action Indicated
Inspection End Date : 2014-11-19
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
District Decision : No Action Indicated
Inspection End Date : 2015-05-06
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
District Decision : Voluntary Action Indicated
Inspection End Date : 2009-04-14
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
District Decision : Voluntary Action Indicated
Inspection End Date : 2010-10-27
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
District Decision : Voluntary Action Indicated
Inspection End Date : 2012-07-20
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
District Decision : No Action Indicated
Inspection End Date : 2012-07-20
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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