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OIG Recommends Improvements for FDA Recalls


The Office of the Inspector General for the Department of Health and Human Services has issued report A-01-16-16-1502, containing recommendations to “improve the strategic coordinated oversight of recall execution”.  A study conducted within the Agency identified deficiencies in FDA initiation of recalls, their monitoring and maintenance of electronic records.  The study revealed that the FDA did not consistently evaluate health hazards in a timely manner and complete audit checks in accordance with procedures or maintain accurate recall data in the digital Recall Enterprise System.

The FDA agreed with the conclusions and recommendations of the Office of the Inspector General and will initiate action to remedy deficiencies to promote public health.


(SMS 064-18 January 9th 2018)