Medical Devices - Change of Manufacturing Location

[SGquality]

I have a question - we have an FDA "Establishment Registration" facility.

The earlier arrangement was that there was a main office (housing Gen Manager, administrative functions incl Human Resources, Customer Service, Purchasing etc.) while the actual manufacturing location (producing parts and having Quality function) was about 5 minutes drive away.

Late last month, the main office was shifted to another location without any change in the actual manufacturing site.

In the FDA Establishment Registration, we had the earlier main office address mentioned which will be changed to the new location.

Is there any way, we could communicate to FDA that there is a change in administrative office with no change in the actual manufacturing facility ? I am in the process of talking to FDA next week but would like to get comments from the group before that.

Thanks in advance.

[v9991]

here are the pertinent guidelines, PMA ...
http://www.fda.gov/MedicalDevices/De.../ucm050467.htm

PMA Manufacturing Site Change Supplement
For moving the manufacturing site if certain conditions apply.
Manufacturing site must have received a Quality System/GMP inspection within the last two years.
If requirements are not met, 180-day PMA Supplement must be submitted.

http://www.fda.gov/MedicalDevices/De.../ucm050467.htm

i am no expert on RA, but as per your discussion, your address of communication is registered at office and that is being shifted; hence you need to communicate it upfront.

[Ronen E]

In Reply to Parent Post by SGquality

I have a question - we have an FDA "Establishment Registration" facility.

The earlier arrangement was that there was a main office (housing Gen Manager, administrative functions incl Human Resources, Customer Service, Purchasing etc.) while the actual manufacturing location (producing parts and having Quality function) was about 5 minutes drive away.

Late last month, the main office was shifted to another location without any change in the actual manufacturing site.

In the FDA Establishment Registration, we had the earlier main office address mentioned which will be changed to the new location.

Is there any way, we could communicate to FDA that there is a change in administrative office with no change in the actual manufacturing facility ? I am in the process of talking to FDA next week but would like to get comments from the group before that.

Thanks in advance.

Hi,

21 CFR 807.3 Definitions:

(c)Establishment means a place of business under one management at one general physical location at which a device is manufactured, assembled, or otherwise processed.

As far as I understand, you should be registering your manufacturing site. It may be overlooked (?) if it's next door from another registered facility, however, if you'd actually have to drive between sites, I would expect a FDA inspector visiting on-site to at least raise a brow.

21 CFR 807.26 Amendments to establishment registration:

Changes in individual ownership, corporate or partnership structure, or location of an operation defined in 807.3(c) shall be submitted on Form FDA-2891(a) at the time of annual registration, or by letter if the changes occur at other times. This information shall be submitted within 30 days of such changes...

I'd say you better hurry and submit the updated details by way of a letter, to meet the 30-days timeframe.

Cheers,
Ronen.

[SGquality]

Thank you ... we changed the address electronically

[Ronen E]

In Reply to Parent Post by SGquality

Thank you ... we changed the address electronically

Thanks for updating us. Did you register both addresses (admin and mfg facilities)?

In Reply to Parent Post by SGquality

I am in the process of talking to FDA next week

(This was posted on 17.6.12)

What did the FDA say?...

Many thanks for whatever you can share,
Ronen.

[SGquality]

Hello Ronen,

We checked if we could file the change electronically or do we have to file this change via letter per the 21 CFR part 807.26 for changes that occur at other times from the annual registration?

Their response was that all registration information (new, updates or annual review) must be submitted electronically using FDA form no 3673 unless FDA grants a waiver from the electronic submission requirement. Hence we opted the electronic route.

We registered the manufacturing location.