Regulatory Open Forum

Dear RAPS community,

For supplier quality management, we want to check Health Authority inspection reports to see if a potential supplier has had significant quality issues and assess the impact on the quality of our products. Accepting suppliers with such issues is not recommended unless there are justifiable reasons. For the US, we know that there is an inspection website:

https://datadashboard.fda.gov/ora/cd/inspections.htm

However, for the EU, I could not find any relevant information on EUDAMED or on the national databases such as BfArM. Do you have any recommendations on how to access this information? Is there a database for quality issue reports that you can recommend? I believe it is important not only to check the inspection records and quality issues in the markets where we want to place our product but also internationally. Any comments or recommendations would be much appreciated.

Best regards,

Jella

Dear RAPS community,

For supplier quality management, we want to check Health Authority inspection reports to see if a potential supplier has had significant quality issues and assess the impact on the quality of our products. Accepting suppliers with such issues is not recommended unless there are justifiable reasons. For the US, we know that there is an inspection website:

https://datadashboard.fda.gov/ora/cd/inspections.htm

However, for the EU, I could not find any relevant information on EUDAMED or on the national databases such as BfArM. Do you have any recommendations on how to access this information? Is there a database for quality issue reports that you can recommend? I believe it is important not only to check the inspection records and quality issues in the markets where we want to place our product but also internationally. Any comments or recommendations would be much appreciated.

Best regards,

Jella

Dear RAPS community,

For supplier quality management, we want to check Health Authority inspection reports to see if a potential supplier has had significant quality issues and assess the impact on the quality of our products. Accepting suppliers with such issues is not recommended unless there are justifiable reasons. For the US, we know that there is an inspection website:

https://datadashboard.fda.gov/ora/cd/inspections.htm

However, for the EU, I could not find any relevant information on EUDAMED or on the national databases such as BfArM. Do you have any recommendations on how to access this information? Is there a database for quality issue reports that you can recommend? I believe it is important not only to check the inspection records and quality issues in the markets where we want to place our product but also internationally. Any comments or recommendations would be much appreciated.

Best regards,

Jella

Dear RAPS community,

For supplier quality management, we want to check Health Authority inspection reports to see if a potential supplier has had significant quality issues and assess the impact on the quality of our products. Accepting suppliers with such issues is not recommended unless there are justifiable reasons. For the US, we know that there is an inspection website:

https://datadashboard.fda.gov/ora/cd/inspections.htm

However, for the EU, I could not find any relevant information on EUDAMED or on the national databases such as BfArM. Do you have any recommendations on how to access this information? Is there a database for quality issue reports that you can recommend? I believe it is important not only to check the inspection records and quality issues in the markets where we want to place our product but also internationally. Any comments or recommendations would be much appreciated.

Best regards,

Jella

Hello Jella-Andrea - thanks for sharing the dashboard for FDA inspections. I was not aware of this website. 

Best regards.

Dear RAPS community,

For supplier quality management, we want to check Health Authority inspection reports to see if a potential supplier has had significant quality issues and assess the impact on the quality of our products. Accepting suppliers with such issues is not recommended unless there are justifiable reasons. For the US, we know that there is an inspection website:

https://datadashboard.fda.gov/ora/cd/inspections.htm

However, for the EU, I could not find any relevant information on EUDAMED or on the national databases such as BfArM. Do you have any recommendations on how to access this information? Is there a database for quality issue reports that you can recommend? I believe it is important not only to check the inspection records and quality issues in the markets where we want to place our product but also internationally. Any comments or recommendations would be much appreciated.

Best regards,

Jella

Dear RAPS community,

For supplier quality management, we want to check Health Authority inspection reports to see if a potential supplier has had significant quality issues and assess the impact on the quality of our products. Accepting suppliers with such issues is not recommended unless there are justifiable reasons. For the US, we know that there is an inspection website:

https://datadashboard.fda.gov/ora/cd/inspections.htm

However, for the EU, I could not find any relevant information on EUDAMED or on the national databases such as BfArM. Do you have any recommendations on how to access this information? Is there a database for quality issue reports that you can recommend? I believe it is important not only to check the inspection records and quality issues in the markets where we want to place our product but also internationally. Any comments or recommendations would be much appreciated.

Best regards,

Jella