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01 2ITF Chemical Ltda
02 1MonoSol LLC
03 5Monosol Rx, Llc
04 4Pharma Tech Industries
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01 5No Action Indicated
02 7Voluntary Action Indicated
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01 12015-04-03
02 12014-11-21
03 12012-09-13
04 12011-08-04
05 12011-06-28
06 12011-03-11
07 12010-03-23
08 12009-06-09
09 12008-11-13
10 12008-10-23
11 22008-10-17
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01 2Camacari, Bahia
02 6Portage
03 4Royston
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01 2BR
02 10US
District Decision : Voluntary Action Indicated
Inspection End Date : 2015-04-03
City : Portage
State : IN
Country/Area : US
Zip : 46368-1234
District : DET
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2015-04-03
District Decision : Voluntary Action Indicated
Inspection End Date : 2014-11-21
City : Royston
State : GA
Country/Area : US
Zip : 30662
District : ATL
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2014-11-21
District Decision : Voluntary Action Indicated
Inspection End Date : 2012-09-13
City : Portage
State : IN
Country/Area : US
Zip : 46368-1234
District : DET
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2012-09-13
District Decision : No Action Indicated
Inspection End Date : 2011-08-04
City : Camacari, Bahia
State :
Country/Area : BR
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2011-08-04
District Decision : Voluntary Action Indicated
Inspection End Date : 2011-06-28
City : Portage
State : IN
Country/Area : US
Zip : 46368-1234
District : DET
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2011-06-28
District Decision : No Action Indicated
Inspection End Date : 2011-03-11
City : Royston
State : GA
Country/Area : US
Zip : 30662
District : ATL
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2011-03-11
District Decision : Voluntary Action Indicated
Inspection End Date : 2010-03-23
City : Portage
State : IN
Country/Area : US
Zip : 46368-1234
District : DET
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2010-03-23
District Decision : No Action Indicated
Inspection End Date : 2009-06-09
City : Portage
State : IN
Country/Area : US
Zip : 46368-1595
District : DET
Center : CFSAN
Project Area : Foodborne Biological Hazards
District Decision : No Action Indicated
Inspection End Date : 2009-06-09
District Decision : Voluntary Action Indicated
Inspection End Date : 2008-11-13
City : Camacari, Bahia
State :
Country/Area : BR
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2008-11-13
District Decision : Voluntary Action Indicated
Inspection End Date : 2008-10-23
City : Portage
State : IN
Country/Area : US
Zip : 46368-1234
District : DET
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2008-10-23