Regulatory Open Forum

Hello All,

My company is moving and I have some questions I am hoping you all can help me with.

We are considered the "manufacturer" for our product, however utilize CMOs for the physical manufacturing.  All we do in our building is distribute and design.  We are moving out of current building into two new buildings.  Our inventory will go to a warehouse/distribution location and our HQ will be in a separate building with no product present except for a show room for customers.  Do we still identify our headquarters on the label regardless of it not having any product?  Do I have to separately register our new distribution/warehouse facility?

How long do we have to switch our labels out?  We have plenty of product on the shelf, is the expectation from the FDA that we will have new labels on everything as soon as the move occurs or is there a grace period applied.

Thanks for any advice you can offer!

Unfortunately, there is no statutory basis upon which the FDA could legally give a grace period for a device labeled with the wrong place of business.  In other words, if the device is labeled with the wrong place of business, then, by law, it must be considered to be “misbranded”.  I know of a couple recent Warning Letters where FDA cited firms for not having the place of business on the label (which is not meaningfully different than having the wrong place of business on the label).

Consequently, in order to avoid misbranding the device after a facility relocation, all device labels, including those on units in inventory, need to be relabeled/over-labeled with the new place of business prior to distribution.  The FDA doesn’t like over-labeling, but will tolerate it if the corresponding GMP controls are achieved.

There is one possible way to avoid having to fix the address; it likely won’t apply in cases where there are questions about new content vs. old content.  But just in case:  If a) the place of business on the current label is (per the conditions in 21 CFR 801.1) represented as just the city and state without the exact street address; and b) the new buildings are in the same city and state as the old building, then no labeling change would be required under the conditions of 801.1.

For a virtual manufacturer who uses a CMO, the appropriate way to handle the establishment registration is for the virtual manufacturer to designate itself in the FURLS database as a particular kind of manufacturer called a “specification developer”.  Thereafter, the address on the device label and in the FURLS database should be that of the specification developer (which is usually the corporate headquarters).  This is okay even if there is no product on hand or manufactured at the specification developer’s place of business.

Finally, the distribution warehouse can take advantage of the statutory (FDAMA) and regulatory [21 CFR 807.20(c)] exemption from establishment registration that is available to wholesale distributors as long as two conditions are met:  a) the distribution warehouse performs no manufacturing, processing, repackaging, or relabeling, and b) it is located in the United States.

Hope this helps,

Oops, I forgot to mention that the exemption from registration for the distribution warehouse also requires that the domestic warehouse not be functioning as an "initial importer".

Thank you both for the detailed responses.  This information is extremely helpful.

Now, this leads me to another question....  If our medical devices include HCTPs (bone graft) will we need to register the warehouse separately from the HQ location for the storage of the tissue *per 807.20 (d)? (all we will be doing at the new warehouse location for tissue will be storage post sterile packaging to complete orders from distributors and hospitals)

Again,

Thank you!

Hello All,

My company is moving and I have some questions I am hoping you all can help me with.

We are considered the "manufacturer" for our product, however utilize CMOs for the physical manufacturing.  All we do in our building is distribute and design.  We are moving out of current building into two new buildings.  Our inventory will go to a warehouse/distribution location and our HQ will be in a separate building with no product present except for a show room for customers.  Do we still identify our headquarters on the label regardless of it not having any product?  Do I have to separately register our new distribution/warehouse facility?

How long do we have to switch our labels out?  We have plenty of product on the shelf, is the expectation from the FDA that we will have new labels on everything as soon as the move occurs or is there a grace period applied.

Thanks for any advice you can offer!

Don’t forget to update the DUNS number. This is important, because you will now have two physical addresses instead of just one.

Also, be sure to coordinate your GUDID entries with the move. The DI Record includes the DUNS number, so be sure to assign the correct address to the DUNS number in GUDID.

I’ve also copied the GUDID information about the DUNS number.

"Choose appropriate DUNS Number from drop down LOV.

To ensure data consistency for the GUDID, DUNS number submitted to the GUDID should associate to the company name that appears on the device label; ideally the address associated with the DUNS number should also match the address on the device label, but since address is not displayed to the GUDID public user, this is not a requirement for data consistency. 

All edits to information connected to the Labeler DUNS Number must be done through Dun & Bradstreet.  No edits of DUNS information will be permitted in the GUDID.  "