Elsmar Cove Forum Header Graphic The Elsmar Cove Wiki More Free Files The Elsmar Cove Forums Discussion Thread Index Post Attachments Listing Failure Modes Services and Solutions to Problems Elsmar cove Forums Main Page Elsmar Cove Home Page
NQA-USA
NQA-USA
Miner's MSA (Measurement Systems Analysis) Blog 
Go Back   The Elsmar Cove Forum > ISO (International Organization for Standardization) Standards > ISO 22000, HACCP (21 CFR 120) and Food Safety
Forum Username

Search the Elsmar Cove
Search Elsmar
Monitor the Elsmar Forum
Follow Marc & Elsmar
Elsmar Cove Forum RSS Feed  Marc Smith's Google+ Page  Marc Smith's Linked In Page   Marc Smith's Elsmar Cove YouTube Page  Marc Smith's Facebook Page  Elsmar Cove Twitter Feed
Elsmar Cove Groups
Elsmar Cove Google+ Group  Elsmar Cove LinkedIn Group  Elsmar Cove Facebook Group
Donate and $ Contributor Forum Access
Courtesy Quick Links

Links that Elsmar Cove visitors will find useful in your quest for knowledge:

Howard's
International Quality Services
Marcelo Antunes'
SQR Consulting
Bob Doering's
Correct SPC - Precision Machining

NIST's Engineering Statistics Handbook
IRCA - International Register of Certified Auditors
SAE - Society of Automotive Engineers
Quality Digest Portal
IEST - Institute of Environmental Sciences and Technology
ASQ - American Society for Quality
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  #1  
Old 27th October 2005, 06:56 PM
sherlok sherlok is offline
Shy Poster (1 to 5 Posts)

 
Registration Date: May 2004
Location: new zealand
 
Posts: 3
Thanks Given to Others: 0
Thanked 0 Times in 0 Posts
Karma Power: 43
Karma: 10
sherlok has less than 100 Karma points so far.
Please Help! Establishment registration - Starting to split the business into seperate divisions

Hi
I work for a medical device manufacturer based outside the US. Due to growth we are starting to split the business into seperate divisions, with a common QMS. In the coming months one of the divisions will move to a new building and this has lead to the question of whether we should register this as a seperate establishment.
Has anyone had experience of a similar situation? is it even possible? the perceived benefits are that if one division did run into difficulties with the FDA, the other divisions (provided we develop a more independant QMS in each) would be unaffected. We would be considered a small manufacturer by US standards <1000 employees

Thanks, Kevin

Sponsored Links
  #2  
Old 27th October 2005, 08:38 PM
Marc's Avatar
Marc Marc is online now
Your Elsmar Cove Host

 
Registration Date: Jan 1996
Location: Olde West Chester - Southern Ohio - USA
Age: 64
 
Posts: 24,340
Thanks Given to Others: 9,898
Thanked 5,432 Times in 3,407 Posts
Blog Entries: 4
Karma Power: 400
Karma: 33302
Marc is appreciated, and has over 1700 Karma points.Marc is appreciated, and has over 1700 Karma points.Marc is appreciated, and has over 1700 Karma points.
Marc is appreciated, and has over 1700 Karma points.Marc is appreciated, and has over 1700 Karma points.Marc is appreciated, and has over 1700 Karma points.Marc is appreciated, and has over 1700 Karma points.
What standard are you referring to?

__________________

A Search is a terrible thing to waste!
One Test is Worth 1000 Expert Opinions - The plural of anecdote is not data - Correlation does not imply Causation
We can't solve problems by using the same kind of thinking we used when we created them. - Unknown
Sponsored Links

  #3  
Old 27th October 2005, 10:31 PM
Al Rosen's Avatar
Al Rosen Al Rosen is offline
Super Moderator

 
Registration Date: Jun 2002
Location: Lawn Guyland
Age: 64
 
Posts: 3,547
Thanks Given to Others: 71
Thanked 754 Times in 458 Posts
Karma Power: 419
Karma: 7270
Al Rosen is appreciated, and has over 1700 Karma points.Al Rosen is appreciated, and has over 1700 Karma points.
Al Rosen is appreciated, and has over 1700 Karma points.Al Rosen is appreciated, and has over 1700 Karma points.Al Rosen is appreciated, and has over 1700 Karma points.Al Rosen is appreciated, and has over 1700 Karma points.Al Rosen is appreciated, and has over 1700 Karma points.Al Rosen is appreciated, and has over 1700 Karma points.Al Rosen is appreciated, and has over 1700 Karma points.Al Rosen is appreciated, and has over 1700 Karma points.Al Rosen is appreciated, and has over 1700 Karma points.
Send a message via AIM to Al Rosen
Quote:
In Reply to Parent Post by sherlok

Hi
I work for a medical device manufacturer based outside the US. Due to growth we are starting to split the business into seperate divisions, with a common QMS. In the coming months one of the divisions will move to a new building and this has lead to the question of whether we should register this as a seperate establishment.
Has anyone had experience of a similar situation? is it even possible? the perceived benefits are that if one division did run into difficulties with the FDA, the other divisions (provided we develop a more independant QMS in each) would be unaffected. We would be considered a small manufacturer by US standards <1000 employees

Thanks, Kevin
I believe if you read the regulation, 21cfr807.40, for foreign establishments you will see you can have only one US agent. So your scheme to do an end run around the law will not succeed since it does not matter how many buildings you have registered. BTW, you need to register each location. The entire regulation can be found in Part 807.

__________________

Al
  #4  
Old 27th October 2005, 10:35 PM
Al Rosen's Avatar
Al Rosen Al Rosen is offline
Super Moderator

 
Registration Date: Jun 2002
Location: Lawn Guyland
Age: 64
 
Posts: 3,547
Thanks Given to Others: 71
Thanked 754 Times in 458 Posts
Karma Power: 419
Karma: 7270
Al Rosen is appreciated, and has over 1700 Karma points.Al Rosen is appreciated, and has over 1700 Karma points.
Al Rosen is appreciated, and has over 1700 Karma points.Al Rosen is appreciated, and has over 1700 Karma points.Al Rosen is appreciated, and has over 1700 Karma points.Al Rosen is appreciated, and has over 1700 Karma points.Al Rosen is appreciated, and has over 1700 Karma points.Al Rosen is appreciated, and has over 1700 Karma points.Al Rosen is appreciated, and has over 1700 Karma points.Al Rosen is appreciated, and has over 1700 Karma points.Al Rosen is appreciated, and has over 1700 Karma points.
Send a message via AIM to Al Rosen
Quote:
In Reply to Parent Post by Marc

What standard are you referring to?
Marc, it must be the FDA QSR, 21cfr820, as far as the FDA is concerned.

__________________

Al
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Forum > ISO (International Organization for Standardization) Standards > ISO 22000, HACCP (21 CFR 120) and Food Safety

Do you find this discussion thread helpful and informational?


Bookmarks


Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
FDA Establishment Registration for Software Company dd1229 US Food and Drug Administration (FDA) 8 18th October 2011 08:39 AM
Registration Renewal of Drug Establishment ireneNJ US Food and Drug Administration (FDA) 3 20th June 2011 08:52 AM
Is there a difference between Establishment Registration Number and FEI? Le Chiffre US Food and Drug Administration (FDA) 1 18th January 2010 01:36 PM
FDA Establishment Registration - Does registration require compliance to the QSR? Quality Queen ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems 8 13th April 2004 03:20 PM
Simultaneous or Staggered registration for two divisions of one company ROMALLEY Registrars (Certification Bodies) and Registration 1 15th August 2002 12:00 PM



The time now is 04:21 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.


   


Marc Timothy Smith - Elsmar.com
8466 LeSourdsville-West Chester Road, Olde West Chester, Ohio 45069-1929
513 341-6272
NOTE: This forum uses "cookies".