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01 2ITF Chemical Ltda

02 1MonoSol LLC

03 5Monosol Rx, Llc

04 4Pharma Tech Industries

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PharmaCompass

01

FDA Audited

USA
Pharmtech & Ingredients
Not Confirmed
arrow

FDA Audited

USA
arrow
Pharmtech & Ingredients
Not Confirmed

ITF CHEMICAL LTDA

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

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02

FDA Audited

USA
Pharmtech & Ingredients
Not Confirmed
arrow

FDA Audited

USA
arrow
Pharmtech & Ingredients
Not Confirmed

Pharma Tech Industries

City : Royston

State : GA

Country/Area : US

Zip : 30662

District : ATL

Center : CFSAN

Project Area : Colors and Cosmetics Technology

District Decision : No Action Indicated

Inspection End Date : 2008-10-17

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03

FDA Audited

USA
Pharmtech & Ingredients
Not Confirmed
arrow

FDA Audited

USA
arrow
Pharmtech & Ingredients
Not Confirmed

ITF CHEMICAL LTDA

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

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04

FDA Audited

USA
Pharmtech & Ingredients
Not Confirmed
arrow

FDA Audited

USA
arrow
Pharmtech & Ingredients
Not Confirmed

Pharma Tech Industries

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 : 2008-10-17

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05

FDA Audited

USA
Pharmtech & Ingredients
Not Confirmed
arrow

FDA Audited

USA
arrow
Pharmtech & Ingredients
Not Confirmed

Pharma Tech Industries

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

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06

FDA Audited

USA
Pharmtech & Ingredients
Not Confirmed
arrow

FDA Audited

USA
arrow
Pharmtech & Ingredients
Not Confirmed

Pharma Tech Industries

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

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07

FDA Audited

USA
Pharmtech & Ingredients
Not Confirmed
arrow

FDA Audited

USA
arrow
Pharmtech & Ingredients
Not Confirmed

MonoSol Rx

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

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08

FDA Audited

USA
Pharmtech & Ingredients
Not Confirmed
arrow

FDA Audited

USA
arrow
Pharmtech & Ingredients
Not Confirmed

MonoSol Rx

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

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09

FDA Audited

USA
Pharmtech & Ingredients
Not Confirmed
arrow

FDA Audited

USA
arrow
Pharmtech & Ingredients
Not Confirmed

MonoSol Rx

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

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10

FDA Audited

USA
Pharmtech & Ingredients
Not Confirmed
arrow

FDA Audited

USA
arrow
Pharmtech & Ingredients
Not Confirmed

MonoSol Rx

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

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