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PHARMACEUTICAL 483 SAMPLER

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If today an FDA auditor comes to your operation site, there is a 54.1% that you will receive a dreaded 483-form full of non compliance observations. On 2010 the FDA issued 646 483’s to the pharmaceutical plants they visited. The question then becomes how to prepare or mitigate the probability of receiving a 483 observation? We believe that the best way to prepare for this occurrence is to gain experience from past examples of 483’s observations and use them as Business Cases Studies. Case studies illustrate psychological principles and Technical knowledge in a way that abstract generalizations and statistics cannot