Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

I have a situation where a company is moving all medical device manufacturing into temporary storage. They still have units already produced in the market for sale. Can they sell those units after they have moved all manufacturing into temporary storage? What about the FDA establishment listing (can/should they list the office, where the temporary storage for all manufacturing parts will be, as the address on the labeling) and ISO 13485 certification in this temporary storage situation (can they be certified when manufacturing is not happening during the storage time)? The company plans to move into a new manufacturing location after more funding is received which might take 9 months to a year.  [PS. dare i say how awful this lack of funding for start-ups is right now...] Thanks for any answers/advice.

Hello Anon

Write a quality plan that starts by clearly defining what finished and unfinished product is where and what activities will continue to be performed where and by whom. You will discover many more questions than already asked here, and each one will need a clearly documented answer.

Not sure what all you're planning to move to a temporary location... finished devices, components, people, manufacturing activities, service activities, sales and shipping, complaint handling?

Yes, if you're doing manufacturing or distribution, registration is required, and it's important to keep your address up to date.

Yes, devices in the market can continue to be sold and resold.

If you're doing manufacturing activities in a new location, this may constitute a significant change, with requirements for risk assessment, process validation, PMA or 510k evaluations, etc.

The documented company address should be a place where FDA people can find the company people/activities. Telephone numbers and email addresses are more useful for customers, and fortunately more portable.

Yes, it's possible to have ISO 13485 audits, site visits, and certification in any location, but it may not be possible to certify compliance for whichever activities aren't happening and can't be observed.

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Anne LeBlanc
United States
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Original Message:
Sent: 14-Jun-2023 23:37
From: Anonymous Member
Subject: Moving manufacturing

This message was posted by a user wishing to remain anonymous

I have a situation where a company is moving all medical device manufacturing into temporary storage. They still have units already produced in the market for sale. Can they sell those units after they have moved all manufacturing into temporary storage? What about the FDA establishment listing (can/should they list the office, where the temporary storage for all manufacturing parts will be, as the address on the labeling) and ISO 13485 certification in this temporary storage situation (can they be certified when manufacturing is not happening during the storage time)? The company plans to move into a new manufacturing location after more funding is received which might take 9 months to a year.  [PS. dare i say how awful this lack of funding for start-ups is right now...] Thanks for any answers/advice.

This question has multiple layers which require attention. I had a client go through this part in Europe for their FDA registered products, had to jump multiple hoops as they had wide range of products. Temporary storage - is the storage facility compliant to store the device, if yes make a quality plan with the stock manufacturing date from which date to which date the stock is created, how long will it be stored in the facility before entering distribution. The warehouse should have appropriate quality management systems in place to ensure the integrity and traceability of the stored devices. This may include implementing storage conditions that meet the manufacturer's specifications, maintaining proper inventory control, and ensuring appropriate handling and storage practices.

How about sales, servicing , complaint handling, where does this activity being held, if there is a change in process please record it in quality system.  any change in servicing, complaints contact like phone number or email or return address, make a note in the IFU/service document and make sure quality system document is updated to reflect any changes .

in the new facility document and validate IQ, OQ, and PQ to validate the process. when moving to new facility you make sure it is registered before you commence manufacturing. Look at your stock plan in advance give time for facility qualification, certification and registration before the first batch is manufactured. Have all processes updated to reflect new facility. Make a change control document and analyze all processes that is affected because of the facility change. Any questions please let me know happy to help.

------------------------------
Raje Devanathan
Amerisource Bergen
TPIreg, Innomar Strategies
Senior Manager - Regulatory Affairs, Medical Devices
rdevanathan@tpireg.com
3470 Superior Court
Oakville ON L6L0C4
Canada
------------------------------

Original Message:
Sent: 14-Jun-2023 23:37
From: Anonymous Member
Subject: Moving manufacturing

This message was posted by a user wishing to remain anonymous

I have a situation where a company is moving all medical device manufacturing into temporary storage. They still have units already produced in the market for sale. Can they sell those units after they have moved all manufacturing into temporary storage? What about the FDA establishment listing (can/should they list the office, where the temporary storage for all manufacturing parts will be, as the address on the labeling) and ISO 13485 certification in this temporary storage situation (can they be certified when manufacturing is not happening during the storage time)? The company plans to move into a new manufacturing location after more funding is received which might take 9 months to a year.  [PS. dare i say how awful this lack of funding for start-ups is right now...] Thanks for any answers/advice.

This message was posted by a user wishing to remain anonymous

Thank you Raje Devanathan! I'm just trying to make sure we do not miss any steps as we move into storage and then back out into mfg when we get funding and then find the right location to start mtg again. I'm sure we're not the only start up having to deal with lack of capital funding right now, so I'd love to hear details from anyone who can share ie things to make sure you do during temporary storage and continuing to sell medical devices during transition.

Original Message:
Sent: 16-Jun-2023 08:54
From: Rajeswari Devanathan
Subject: Moving manufacturing

This question has multiple layers which require attention. I had a client go through this part in Europe for their FDA registered products, had to jump multiple hoops as they had wide range of products. Temporary storage - is the storage facility compliant to store the device, if yes make a quality plan with the stock manufacturing date from which date to which date the stock is created, how long will it be stored in the facility before entering distribution. The warehouse should have appropriate quality management systems in place to ensure the integrity and traceability of the stored devices. This may include implementing storage conditions that meet the manufacturer's specifications, maintaining proper inventory control, and ensuring appropriate handling and storage practices.

How about sales, servicing , complaint handling, where does this activity being held, if there is a change in process please record it in quality system.  any change in servicing, complaints contact like phone number or email or return address, make a note in the IFU/service document and make sure quality system document is updated to reflect any changes .

in the new facility document and validate IQ, OQ, and PQ to validate the process. when moving to new facility you make sure it is registered before you commence manufacturing. Look at your stock plan in advance give time for facility qualification, certification and registration before the first batch is manufactured. Have all processes updated to reflect new facility. Make a change control document and analyze all processes that is affected because of the facility change. Any questions please let me know happy to help.

------------------------------
Raje Devanathan
Amerisource Bergen
TPIreg, Innomar Strategies
Senior Manager - Regulatory Affairs, Medical Devices
rdevanathan@tpireg.com
3470 Superior Court
Oakville ON L6L0C4
Canada

Original Message:
Sent: 14-Jun-2023 23:37
From: Anonymous Member
Subject: Moving manufacturing

This message was posted by a user wishing to remain anonymous

I have a situation where a company is moving all medical device manufacturing into temporary storage. They still have units already produced in the market for sale. Can they sell those units after they have moved all manufacturing into temporary storage? What about the FDA establishment listing (can/should they list the office, where the temporary storage for all manufacturing parts will be, as the address on the labeling) and ISO 13485 certification in this temporary storage situation (can they be certified when manufacturing is not happening during the storage time)? The company plans to move into a new manufacturing location after more funding is received which might take 9 months to a year.  [PS. dare i say how awful this lack of funding for start-ups is right now...] Thanks for any answers/advice.