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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