Tsedenia Woldehanna and Rose Xu from CDER’s Office of Pharmaceutical Quality discuss inspection trends and facility submission expectations in view of the 356H form.

Woldehanna discusses inspectional findings, text analytics tools, emerging topics and most frequently cited 483 observations and citations to CFRs.

Xu shares the agency’s expectation of information needed in the 356 H form in order to avoid errors and prevent delay of approval of applications.

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