Regulatory Open Forum

Hello everyone, 

I would appreciate your advice and insights regarding the following.

We have been notified by one of our critical suppliers through a letter that they are in the process of relocating their warehouses and distribution centers to new locations. 

what activities do we need to do internally to document such change? does this require a design change? 

Thank you. 

File the letter in the supplier's file. Presumably the letter includes information about the locations, such as temperature, humidity, stock rotation, etc. that is equal to or better than the current location. If not, determine the factors that make this supplier critical and ask for the information.

There is a question of a visit to the new location or even a quality audit. Given adequate assurances, just follow the strategy you used for the current location. For example, if you didn't do second party audits at the current location, don't do them at the new location. If there are third party audit reports, be sure to get them for the new location.

This activity doesn't require a design change, because your product has not changed.<o:p></o:p>

Hello everyone, 

I would appreciate your advice and insights regarding the following.

We have been notified by one of our critical suppliers through a letter that they are in the process of relocating their warehouses and distribution centers to new locations. 

what activities do we need to do internally to document such change? does this require a design change? 

Thank you. 

Original poster did not identify if the product in question was cleared or approved.  If the product came to market via PMA, the analysis may be a bit more complex.  If the supplier of the critical component moves operations to a location with a different FEI, FDA may consider this to be a change in supplier of a critical component, for which they request a 30-day notice.

Original Message:
Sent: 09-Aug-2023 09:34
From: Dan O'Leary
Subject: New warehouse/distribution centers for critical supplier

File the letter in the supplier's file. Presumably the letter includes information about the locations, such as temperature, humidity, stock rotation, etc. that is equal to or better than the current location. If not, determine the factors that make this supplier critical and ask for the information.

There is a question of a visit to the new location or even a quality audit. Given adequate assurances, just follow the strategy you used for the current location. For example, if you didn't do second party audits at the current location, don't do them at the new location. If there are third party audit reports, be sure to get them for the new location.

This activity doesn't require a design change, because your product has not changed.<o:p></o:p>

Hello everyone, 

I would appreciate your advice and insights regarding the following.

We have been notified by one of our critical suppliers through a letter that they are in the process of relocating their warehouses and distribution centers to new locations. 

what activities do we need to do internally to document such change? does this require a design change? 

Thank you.