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Trusting ISO 13485 Certification of a Supplier... A Sad Story - Page 2


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Some Related Topic Tags (Not all threads are Tagged)
fda (food and drug administration), fda form 483 or warning letter, iso 13485 - medical device qms, medical device company or industry
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  Post Number #9  
Old 8th September 2011, 10:45 AM
Doug Tropf

 
 
Total Posts: 396
Re: Trust of ISO13485 Certification... A Sad Story

They apparently are not all published as I recently had to apply for a copy of an FDA warning letter through the Freedom of Information Act.
Thanks to Doug Tropf for your informative Post and/or Attachment!

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  Post Number #10  
Old 8th September 2011, 11:16 AM
Sidney Vianna's Avatar
Sidney Vianna

 
 
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Re: Trust of ISO13485 Certification... A Sad Story

Quote:
In Reply to Parent Post by Doug Tropf View Post

They apparently are not all published as I recently had to apply for a copy of an FDA warning letter through the Freedom of Information Act.
FDA Warning letters are available @ http://www.fda.gov/ICECI/Enforcement...rs/default.htm You can even subscribe to receive updates via this link.
Thanks to Sidney Vianna for your informative Post and/or Attachment!
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  Post Number #11  
Old 8th September 2011, 12:43 PM
Bev D's Avatar
Bev D

 
 
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Re: Trust of ISO13485 Certification...A Sad Story

Quote:
In Reply to Parent Post by Sidney Vianna View Post

What about keeping the CB responsible for the supplier ISO 13485 certificate accountable?
exactly. the fda should also be investigating all certifying bodies for this organization. The WHOLE point of this proliferation of "TLA-XXXX whatever" standards over the last two+ decades was to get Customers out of the business of auditing their suppliers as it is a collosal expense for both parties.

I'm not saying throw the baby out with the bath water - I'm saying let's make all of our third party auditors accountable, professional and valuable.
Thank You to Bev D for your informative Post and/or Attachment!
  Post Number #12  
Old 8th September 2011, 02:23 PM
Doug Tropf

 
 
Total Posts: 396
Re: Trust of ISO13485 Certification... A Sad Story

Quote:
In Reply to Parent Post by Sidney Vianna View Post

FDA Warning letters are available @ http://www.fda.gov/ICECI/Enforcement...rs/default.htm You can even subscribe to receive updates via this link.
I subscribe to receive the warning letter updates however, the particular letter I was interested in was not listed or available at the site. I contacted the FDA and was given instructions on how to request a copy of the letter via the Freedom of Information Act (which I did).
  Post Number #13  
Old 8th September 2011, 03:19 PM
BradM's Avatar
BradM

 
 
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Re: Trust of ISO13485 Certification... A Sad Story

Quote:
In Reply to Parent Post by Doug Tropf View Post

I subscribe to receive the warning letter updates however, the particular letter I was interested in was not listed or available at the site. I contacted the FDA and was given instructions on how to request a copy of the letter via the Freedom of Information Act (which I did).
That's kind of scary. I thought 483 were publicly posted. I wonder why they did not have this one available.
  Post Number #14  
Old 8th September 2011, 03:21 PM
BradM's Avatar
BradM

 
 
Total Posts: 5,930
Re: Trust of ISO13485 Certification... A Sad Story

This thing kind of scares me. How could a company be making direct product-contact material, with essentially no sterility checks of any kind?

To me, that just borders on criminal negligence.
  Post Number #15  
Old 8th September 2011, 03:57 PM
Doug Tropf

 
 
Total Posts: 396
Re: Trust of ISO13485 Certification... A Sad Story

Quote:
In Reply to Parent Post by BradM View Post

That's kind of scary. I thought 483 were publicly posted. I wonder why they did not have this one available.
I wound up exchanging emails with the FDA inspector who wrote the 483 and he advised I would have to go thru the FOIA - no explanation as to why was given.
  Post Number #16  
Old 8th September 2011, 03:58 PM
try2makeit's Avatar
try2makeit

 
 
Total Posts: 102
Re: Trust of ISO13485 Certification... A Sad Story

I have two questions. In the warning letters the FDA sends out with the findings, does the Company not have a responsibility to correct those findings in a reasonable time, just like we in automotive with CA's. Why does it say no date given? And why are there still companies operating, that have received findings last year or the year before? Does the finding determine the date?

My other question is, seeing that the particular companies ISO cert is expiring October 2011, I am wondering if they had their re-cert audit already with the same CB and were re-certified even under the current circumstances. Anyone know?
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