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Statement from FDA on continuing efforts to maintain its strong oversight of generic drugs
date:Feb 25, 2019
ut the reality is that were looking in the riskiest places. So, were better able to spot problems and take action when needed. Our approach appropriately allows for companies to provide a plan for how theyll address issues identified during an inspection, which encourages a culture of quality within manufacturers, supported by smart and efficient regulation.

Findings from inspections are evaluated and classified according to a defined process agreed upon by the CDER and our investigators and st

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