Remote Assessments A Welcome Option For US FDA, But They’re Not Every Firm’s First Choice
“We're looking to expand the use of this tool make it a more routine part of our operations going forward,” says Michael Dutcher, deputy director, ORA Office of Human and Animal Food Operations. “In general, the response from industry has been pretty positive” about RRAs.
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An Oregon factory’s citations received by the FDA are among the most common violations the agency finds during inspections, ORA Office of Human and Animal Food Operations deputy director said.
Agency provides additional details on plans for various remote methods of assessing Rx and OTC drug manufacturing facilities that became popular when investigators were prevented by COVID-19 travel restrictions from visiting sites in person.
"Many of the problems facing [the FDA] can be solved through strong leadership rather than more money,” says Rep. Andy Harris during Appropriations subcommittee hearing, Committee Chairwoman Rosa DeLauro continues her criticism of FDA's regulation of industries under its oversight, saying a "structural problem" caused infant formula shortage.