FDA - Registration & Listing Updating + when Purchasing another Company

A

Audit Consultant

Guest
#1
Please let me know your opinion on this. The question: Does the Registration and Listing Data and any other FDA info. need to be updated in this situation?

One medical device company purchases another. Let's call the purchasing company, "A" and the company being purchased, "B".

Legal documents state that Company B is a Wholly Owned Subsidiary, a separate legal entity. Purchase was announced publicly with press release. Company A assigned a new Pres. and COO paid on payroll of Company A who manages Company B. V.P. Quality and Regulatory of Company B now reports to Company A Head of Regulatory and Quality with dotted line to Company A Pres. and COO.

Company B's address stays the same and manufacturing stays the same.

What needs to be reported or updated to FDA, if anything for registration and any other items as to the purchase?

Since it is a Wholly Owned Subsidiary and Company B is supposed to exist as a separate legal entity does anything need to change?

Please comment. Please also comment on what happens if this is not done and it should have been.

Some links and info. per CDRH - you may have more:

http://www.fda.gov/cdrh/registration/whenupdated.html

From CDRH FAQs:
If I change the address of my establishment or if the owner/operator of the establishment changes, do I have to update the device listings?

If you change the address of your establishment, you do not need to update your device listings. If your establishment is sold to another owner/operator, you will maintain the same registration number and you will need to create new listings for those products that will continue to be produced at the establishment.

What is Establishment Registration
Establishments involved in the production and distribution of medical devices intended for marketing or leasing (commercial distribution) in the United States (U.S.) are required to register with the FDA. This process is known as establishment registration. Registration provides FDA with the location of medical device manufacturing facilities and importers. The regulations for establishment registration are provided in 21 CFR 807. As of October 1, 2007, all establishment registrations must be submitted electronically unless a waiver has been granted by FDA. Congress has also authorized FDA to implement a user fee for certain types of establishment registrations processed after September 30, 2007. Your registration is not considered complete until FDA has been notified that all requirements have been met.

ESTABLISHMENT
Any place of business under one management at one physical location at which a device is manufactured, assembled or otherwise processed for commercial distribution.

OWNER/OPERATOR
The corporation, subsidiary, affiliated company, partnership, or proprietor directly responsible for the activities of the registering establishment. The owner/operator is responsible for registering the establishment.


Thank you.
 

Chris Ford

Quite Involved in Discussions
#2
Re: FDA - Registration & Listing Updating +

I believe you should update your registration to reflect the new owner/operator. While it's a wholly owned subsidiary of the company, the purchasing company has established that it is responsible for the activities of the company it purchased.
 

gar4guv

Inactive Registered Visitor
#3
Re: FDA - Registration & Listing Updating +

I agree with Mr. Ford. As long as company B stays in the same location and makes the same products, it looks like the only thing that needs to be done is update company B's information with the new owner name and address.

While not updating the information can result in a 483 citing, it is something that can be fixed before the inspector leaves the building. Most inspectors will verify that type of info over the phone during the pre-audit notification. That should be more than enough time to identify and correct most registration and listing errors.
 
S

spursqa - 2009

Guest
#4
Re: FDA - Registration & Listing Updating +

Hello,

My company is moving location. All product produced will be exactly the same.

Please can someone advise what needs to be done re FDA Establishment registration?

Many Thanks
 
B

BJMQA

Guest
#6
Re: FDA - Registration & Listing Updating +

If there is a transition period during the move where a manufacturer owns and operates out of both facilites until the lease is up on the old facility and customer approvals of the new facility occur, does each facility need to be registered with the FDA? This would be approximately 5-6 months where both facilities are used. Or can the facility just update the Establishment Registration info once the move is finalized?
 
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MIREGMGR

Inactive Registered Visitor
#7
Re: FDA - Registration & Listing Updating +

My recommendation would be to register both. I don't see a downside, and that way you know that you're covered.
 
B

BJMQA

Guest
#8
Re: FDA - Registration & Listing Updating +

Thanks for the input MIREGMGR and I agree thats the best way to get us covered but the downside for us would be paying registration fees for two registered facilities for two years. The move will of course occur crossing over two years. We are more than willing to pay this if this is what it takes, and if it makes the FDA happy then it makes me happy, but if we can save ourselves the ~$7000 then we would like to do that. Also, we have listed ~120 devices, so thats a fair amount of time to transfer all that info into a new registration. Anyone else have experience with a move?
 
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