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Who's that knocking at the door? Preparing for an FDA inspection

examining equipment, reviewing documents, collecting product samples, and interviewing employees.

At the end of the inspection, if the investigator believes conditions deviate from FDA requirements or violative products exist, the investigator will issue a notice of inspectional observations (called a Form 483). The investigator will review the 483 and each observation with management-lev......

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Source:wistechnology.com By Patricia Kaeding 07/12/05


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