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thank you for the kind introduction my name is jamila harwalka and iamp;#39;m very excited to have the opportunity to speak with you today we are going to discuss why clean rooms and clean room behaviors are important for preventing and sanitary conditions that can adversely impact the quality and safety of drug products for todayamp;#39;s learning objectives we are going to identify the section of the federal food drug and cosmetic act addressing drug products prepared under insanitary conditions we will list different types of filth understand potential sources of filth understand how clean rooms and clean room behaviors prevent or limit the introduction of filth and finally we will discuss multiple examples of 483 observations pertaining to unsanitary conditions so what does the law say section 501a2 of the federal food drug and cosmetic act states that a drug is deemed to be adulterated if it has been prepared packed or held under in sanitary conditions whereby it may have been c
