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FDA Recalls Monitoring: Internal Efficiency Grows, But Website Lags

This article was originally published in The Silver Sheet

Executive Summary

DEVICE RECALLS FALL 10% IN 2003, returning to 2001 level, with 527 actions reported. FDA is using its new Recall Enterprise System to electronically track each recall, but has yet to launch the long-promised public arm of the system. Meanwhile, agency staff say a manufacturer’s overall state of control may be called into question by a recall. "When you call me about a recall, you’re telling me that the quality control system in your firm works or it doesn’t work," says a Detroit compliance officer. To avoid a warning letter after a recall, companies should investigate why the problem occurred and take action to prevent a recurrence, agency staff advise
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