WASHINGTON — The Food and Drug Administration plans to warn companies more quickly about problems found during inspections “to ensure that violations are taken seriously,” according to published reports.
Margaret Hamburg, FDA commissioner, reportedly said in a speech last week the agency would no longer require that all warning letters be reviewed by its lawyers before being sent to violators except in complex cases — a procedure initiated during the Bush administration.
Under the new policy, companies will have 15 working days to respond to the FDA before the agency takes further action, the reports said.
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