Digging for 483 Gold: How to Mine FDA's Inspection Reports - FDAnews
嚜澳igging for 483 Gold: How to Mine
FDA's Inspection Reports
An FDANews Webinar
December 8, 2014
Michael A. Swit, Esq.
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2
? Michael A. Swit, Esq.
What We Will ＃ and Won＊t ＃ Cover
? What We Will Cover:
每 The Data 每 FDA Inspections Statistics
每 Panning the Gold 每 examples of what you can glean from a
483 每 courtesy of
每 How to Respond to a 483
? Not today
每 Conducting an inspection
每 Deep drill down on observations
每 Warning Letters and later enforcement activity
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? Michael A. Swit, Esq.
FDA Inspections 每FY 2014
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? Michael A. Swit, Esq.
483s by All FDA Centers/Program Areas
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? Michael A. Swit, Esq.
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