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.
You may also be interested in...
Supplement facility GMP inspections by FDA in 2022 along with the frequency of form 483s sent to firms following inspections return to roughly pre-pandemic annual numbers after dipping during 2020 and 2021.
CHPA members’ feedback on RRAs indicate that “time and resources saved by FDA do not translate to time saved by the manufacturer.” CRN suggests FDA “clearly identify the purpose of the RRA in its initial request and limit requested documents to only those directly related to the purpose of the RRA.”
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.