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01 5Confab Laboratories Inc.

02 12DPT Lakewood, LLC

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PharmaCompass

01

FDA Audited

USA
Antibody Engineering
Not Confirmed
arrow

FDA Audited

USA
arrow
Antibody Engineering
Not Confirmed

Renaissance Pharma

City : Lakewood

State : NJ

Country/Area : US

Zip : 08701-5938

District : NWJ

Center : CVM

Project Area : Monitoring of Marketed Animal Dr...

District Decision : No Action Indicated

Inspection End Date : 2013-01-17

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02

FDA Audited

USA
Antibody Engineering
Not Confirmed
arrow

FDA Audited

USA
arrow
Antibody Engineering
Not Confirmed

Renaissance Pharma

City : Lakewood

State : NJ

Country/Area : US

Zip : 08701-5938

District : NWJ

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2009-11-03

blank

03

FDA Audited

USA
Antibody Engineering
Not Confirmed
arrow

FDA Audited

USA
arrow
Antibody Engineering
Not Confirmed

Renaissance Pharma

City : Lakewood

State : NJ

Country/Area : US

Zip : 08701-5938

District : NWJ

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2014-11-04

blank

04

FDA Audited

USA
Antibody Engineering
Not Confirmed
arrow

FDA Audited

USA
arrow
Antibody Engineering
Not Confirmed

Renaissance Pharma

City : Lakewood

State : NJ

Country/Area : US

Zip : 08701-5938

District : NWJ

Center : CVM

Project Area : Monitoring of Marketed Animal Dr...

District Decision : No Action Indicated

Inspection End Date : 2009-11-03

blank

05

FDA Audited

USA
Antibody Engineering
Not Confirmed
arrow

FDA Audited

USA
arrow
Antibody Engineering
Not Confirmed

Renaissance Pharma

City : Lakewood

State : NJ

Country/Area : US

Zip : 08701-5938

District : NWJ

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2010-04-28

blank

06

FDA Audited

USA
Antibody Engineering
Not Confirmed
arrow

FDA Audited

USA
arrow
Antibody Engineering
Not Confirmed

Renaissance Pharma

City : Lakewood

State : NJ

Country/Area : US

Zip : 08701-5938

District : NWJ

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2010-06-15

blank

07

FDA Audited

USA
Antibody Engineering
Not Confirmed
arrow

FDA Audited

USA
arrow
Antibody Engineering
Not Confirmed

Renaissance Pharma

City : Lakewood

State : NJ

Country/Area : US

Zip : 08701-5938

District : NWJ

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2011-08-10

blank

08

FDA Audited

USA
Antibody Engineering
Not Confirmed
arrow

FDA Audited

USA
arrow
Antibody Engineering
Not Confirmed

Renaissance Pharma

City : Lakewood

State : NJ

Country/Area : US

Zip : 08701-5938

District : NWJ

Center : CVM

Project Area : Monitoring of Marketed Animal Dr...

District Decision : Voluntary Action Indicated

Inspection End Date : 2011-08-10

blank

09

FDA Audited

USA
Antibody Engineering
Not Confirmed
arrow

FDA Audited

USA
arrow
Antibody Engineering
Not Confirmed

Renaissance Pharma

City : Lakewood

State : NJ

Country/Area : US

Zip : 08701-5938

District : NWJ

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Official Action Indicated

Inspection End Date : 2012-03-07

blank

10

FDA Audited

USA
Antibody Engineering
Not Confirmed
arrow

FDA Audited

USA
arrow
Antibody Engineering
Not Confirmed

Renaissance Pharma

City : Lakewood

State : NJ

Country/Area : US

Zip : 08701-5938

District : NWJ

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2013-01-17

blank