Frequently Requested Inspection Documents on FDA's Website

GMP News No. 509

GMP News
2 February 2005
 

Frequently Requested Inspection Documents
on FDA's Website

 
From time to time people ask us where they can find inspection documents issued by the FDA. Usually, they are familiar with the FDA Warning Letters, which can be searched and displayed directly on this website (just click on "Search" in the top menu). However, according to the Freedom of Information Act (FOI), all of the inspection documents are available. Due to their great number, the FDA only publishes the frequently requested documents on its website. These documents make it possible to follow the exact course of an inspection. For this reason, it is very useful to have a look at these documents before an FDA inspection as they give you insight into the question to which points the FDA inspectors give special attention. They also show the differences in the judgement by the individual FDA inspectors.

Another interesting thing is the course of the inspections and the follow-up. The FDA page includes the 483 forms, i.e. the inspection reports, as well as the Establishment Inspection Reports (EIR), which are written after the inspection. Sometimes, the EIR gives you a different impression of the inspection than the corresponding 483 form. All in all, this is important literature for improving your GMP compliance. Please click here in order to view the Frequently Requested ORA Documents and FDA 483s.

Author:
Oliver Schmidt
CONCEPT HEIDELBERG

  

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