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01 8Adare Pharmaceuticals Inc.
02 5Adare Pharmaceuticals Srl
03 3Aptalis Pharma Us Inc
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01 8No Action Indicated
02 2Official Action Indicated
03 6Voluntary Action Indicated
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01 12019-01-25
02 12018-07-11
03 12018-04-13
04 12017-05-19
05 12017-02-24
06 12014-11-14
07 12014-05-30
08 12014-04-16
09 22013-08-29
10 12012-11-16
11 12012-07-19
12 12011-12-21
13 12011-06-17
14 12009-11-20
15 12009-10-09
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01 3Birmingham
02 5Pessano Con Bornago
03 8Vandalia
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01 5IT
02 11US
District Decision : No Action Indicated
Inspection End Date : 2019-01-25
City : Vandalia
State : OH
Country/Area : US
Zip : 45377-3129
District : CIN
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2019-01-25
District Decision : No Action Indicated
Inspection End Date : 2018-07-11
City : Vandalia
State : OH
Country/Area : US
Zip : 45377-3129
District : CIN
Center : CDER
Project Area : Postmarket Surv. and Epidemiolog...
District Decision : No Action Indicated
Inspection End Date : 2018-07-11
District Decision : Voluntary Action Indicated
Inspection End Date : 2018-04-13
City : Pessano Con Bornago
State :
Country/Area : IT
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2018-04-13
District Decision : No Action Indicated
Inspection End Date : 2017-05-19
City : Vandalia
State : OH
Country/Area : US
Zip : 45377-3129
District : CIN
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2017-05-19
District Decision : Voluntary Action Indicated
Inspection End Date : 2017-02-24
City : Pessano Con Bornago
State :
Country/Area : IT
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2017-02-24
District Decision : Voluntary Action Indicated
Inspection End Date : 2014-11-14
City : Vandalia
State : OH
Country/Area : US
Zip : 45377-3129
District : CIN
Center : CDRH
Project Area : Compliance: Devices
District Decision : Voluntary Action Indicated
Inspection End Date : 2014-11-14
District Decision : Voluntary Action Indicated
Inspection End Date : 2014-05-30
City : Pessano Con Bornago
State :
Country/Area : IT
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2014-05-30
District Decision : No Action Indicated
Inspection End Date : 2014-04-16
City : Birmingham
State : AL
Country/Area : US
Zip : 35242-4887
District : NOL
Center : CDRH
Project Area : Compliance: Devices
District Decision : No Action Indicated
Inspection End Date : 2014-04-16
District Decision : Official Action Indicated
Inspection End Date : 2013-08-29
City : Birmingham
State : AL
Country/Area : US
Zip : 35242-4887
District : NOL
Center : CDRH
Project Area : Compliance: Devices
District Decision : Official Action Indicated
Inspection End Date : 2013-08-29