08.10.2018 Views

My Reading on ASQ CQA HB Part I-IA~IE-s

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IE2-Gossip<br />

For FDA audits of organizati<strong>on</strong>s, the FDA typically will not request to<br />

see internal audit reports but will ask to see evidence that scheduled<br />

audits were performed. In some cases where there is a serious issue,<br />

the FDA may require review of the internal audit report c<strong>on</strong>tent to<br />

evaluate whether the issue had been found during internal audits.<br />

The potential audiences of the reports should be kept in mind when the<br />

reports are written.<br />

FDA: US Food and Drug Administrati<strong>on</strong><br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang

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