Breakdown and Analysis of FDA Warning Letters

[Fifi2006]

Hi,

I am currently doing research work in the area of global regulation. I am researching the regulatory landscape for the Medical Device Industry. As part of this exercise I want to review a breakdown of FDA Warning Letters (if such information is available). I am fully aware that you can access the Warning Letters on the FDA website. I am seeking the analysis of these Warning Letters. I was wondering if any one knows where I could get this type of analysis e.g the top cited issues within Warning Letters, trends, improvements...etc.

All help welcome!

F.

 

[Sidney Vianna]

Re: Analysis of FDA Warning Letters?

• Browse Warning Letters by Company
• Browse Warning Letters by Issuing Office
• Browse Warning Letters by Subject
• Browse Warning Letters with Response Letters
• Browse Warning Letters with Closeout Letters
• Advanced Search

To download information about Warning Letters to an Excel document:​

• Use the Search and Export Warning Letters to Excel function.

​

Hope this helps.

 

[MIREGMGR]

Re: Analysis of FDA Warning Letters?

I don't know of any publically available, already-compiled analysis such as you seek.

 

[Reiko Shiratori]

Re: Analysis of FDA Warning Letters?

I am not sure this is what you are looking for, but...

This is from MasterControl, a GMP/QMS software company.

I hope this helps you.

Reiko

 

[v9991]

1) heres another reference, but this seems to be just an overview/generic in nature...
Just in case if you have missed the following link
http://www.eyeonfda.com/eye_on_fda/warning_letters/

http://www.circare.org/FOIA/warninglettertables.htm
http://www.pharmcast.com/WarningLetters/CompanyWL.htm
http://www.gmp-compliance.org/eca_news_870.html

2)Surely you would find couple of commercial/paid services online; where you could get requisite information. viz.,
http://www.gmppublications.com/meddevice.htm
fda,con

3) i had personally carried out an exercise [covering 2008-08] to find out the focus/distribution of warning letters on the industry [clinical studies, pharma and medical devices etc.,] and further on various quality/operations processes. If you could specify the exact details which you are looking for, i will try to share the ppt,[ if its relevant]

thanks
Valiveti.

 

[Ajit Basrur]

Re: Analysis of FDA Warning Letters?

I am not sure this is what you are looking for, but...

This is from MasterControl, a GMP/QMS software company.

I hope this helps you.

Reiko

Reikosan, thanks for the white paper - very informative

 

[Nikunj]

Dear Valiveti,

I am Nikunj Vasoya. I am presently doing my research on trend analysis in warning letters in last two years (specially those issued for Medical Device). I will be very thankful to you, if you can share your power point presentation or research paper with me. Thank you in advance. have a great day.

Regards,
Nikunj Vasoya

 

[fsmaggie]

I have a novice question for you all; is there any affordable Document/Control Control type software out there for small businesses? We are trying to respond to our 483. The FDA came by for unexpected inspection and we now have to file for registration and re-classification. Where should one start?

Any feedback is greatly appreciated.

Thank you.

 

[Doug Tropf]

I have a novice question for you all; is there any affordable Document/Control Control type software out there for small businesses? We are trying to respond to our 483. The FDA came by for unexpected inspection and we now have to file for registration and re-classification. Where should one start?

Any feedback is greatly appreciated.

Thank you.

Was the citation(s) listed on your 483 document control related? You are probably going to have to provide more details to receive meaningful feedback.

 

[molecs]

Hi -

There are compiled books available on Amazon. Just search for "fda warning letters medical device gmp"