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FDA Inspection Guide to MD - New Web Portal for Inspectional Database

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sreenu927

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#1
Hi All,

1. I think many of you might have aware of the new release of FDA Inspection Guide to Medical Device Manufacturers.

Who are not aware, have the attachment.

2. FDA warning letters: analysis of quality system data, as attached.

3. FDA to make enforcement and compliance activities accessible online
New Web portal to include searchable database

Below is the url link from FDA website related to FDA initiatives to have the transparency on inspections (Form 483 (List of Observations), Sites Inspected (Inspections database) ) and so much information available.

This is very useful!!

http://www.fda.gov/AboutFDA/Transparency/TransparencyInitiative/ucm254426.htm

Regards,
Sreenu
 

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