System-level FDA Recall Management

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Bryan R Bailey
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System-level FDA Recall Management

Greetings,

Does anybody have a system-level policy/process regarding management of recalls for pharmaceuticals, medical equipment/devices, etc they could share? I’m specifically interested in any policies/mechanisms that include requirements for individual facilities to report back to system leadership about recall impact and actions taken in response to a recall (e.g., quantity on hand, quantity unaccounted for, removal of product from stock completed, # of patients affected, level of patient harm, was patient notification necessary, patient notification completed).

I appreciate any feedback you can provide.

Bryan Bailey

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