Comments on: FDA Begins Enforcing Deadlines on Form 483 Responses http://blog.pharmtech.com/2009/09/15/fda-begins-enforcing-deadlines-on-form-483-responses/ The blog of Pharmaceutical Technology magazine Thu, 09 May 2013 23:30:55 -0400 http://wordpress.org/?v=2.8.4 hourly 1 By: Sirmiu http://blog.pharmtech.com/2009/09/15/fda-begins-enforcing-deadlines-on-form-483-responses/comment-page-1/#comment-21806 Sirmiu Thu, 15 Oct 2009 05:56:26 +0000 http://blog.pharmtech.com/?p=1829#comment-21806 Thanks for your article. That's a very important step to achieve a fast and effective enforcement by FDA. This step should have been taken earlier. Thanks for your article. That’s a very important step to achieve a fast and effective enforcement by FDA. This step should have been taken earlier.

]]> By: Carl Anderson http://blog.pharmtech.com/2009/09/15/fda-begins-enforcing-deadlines-on-form-483-responses/comment-page-1/#comment-21403 Carl Anderson Sat, 26 Sep 2009 03:49:14 +0000 http://blog.pharmtech.com/?p=1829#comment-21403 This is a very important development by FDA. As a former FDA field investigator, I understand the importance of responding to FDA when an FDA 483 is issued. It is important to note that the 483 is Not the final compliance determination by the agency. It is the preliminary observations of the field investigator. It is in the best interests of the inspected party to respond effectively to a 483. Now we know that it is also important to respond in a timely manner. I have an article about FDA 483s on my blog, Carl's Blog on FDA Stuff. PharmTech has been kind enough to put my blog on their Blogroll (on the right). This is an important development regarding FDA enforcement standards with a new commissioner and a new policy on "Effective Enforcement." Thanks for an excellent post. This is a very important development by FDA. As a former FDA field investigator, I understand the importance of responding to FDA when an FDA 483 is issued. It is important to note that the 483 is Not the final compliance determination by the agency. It is the preliminary observations of the field investigator. It is in the best interests of the inspected party to respond effectively to a 483. Now we know that it is also important to respond in a timely manner.

I have an article about FDA 483s on my blog, Carl’s Blog on FDA Stuff. PharmTech has been kind enough to put my blog on their Blogroll (on the right). This is an important development regarding FDA enforcement standards with a new commissioner and a new policy on “Effective Enforcement.” Thanks for an excellent post.

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