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Margaret Hamburg's FDA: More Inspections, Tougher Follow-Up On Violations

This article was originally published in The Silver Sheet

Executive Summary

MANUFACTURERS SHOULD BE PREPARED FOR RAPID ACTION FROM FDA when an inspection finds problems, agency officials are saying. FDA Commissioner Margaret Hamburg has promised to step up the agency's enforcement efforts, and the device center is falling into line with the new mandate. "When we determine that quality systems are out of place or that there may be a public health risk, then we are going to follow up on those things much faster than we have in the past," says Larry Spears, deputy director of regulatory affairs in CDRH's Office of Compliance. In addition, the number of FDA inspections has grown considerably over the past year thanks to a marked increase in congressional funding. "We're really happy that we're getting the money and the people to finally do what we're supposed to be doing," Baltimore District Office Director Evelyn Bonnin says. Industry experts also share tips to help firms prepare for inspections, and FDA officials tell what investigators will look at when visiting a manufacturing facility

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