US FDA Inspection In Store? Here Are Some Areas That May Be On Agency’s Radar

A recent workshop in Mumbai examined a host of issues around data integrity in manufacturing and beyond, including what US FDA inspectors are focusing on, areas where lapses are most prominent and the importance of tackling cultural gaps along the journey toward compliance.

Frances Zipp, CEO of Lachman Consultant Services, Inc., told the workshop on data integrity, data reliability and quality metrics that based on the consultancy’s review of publicly available US Food and Drug Administration inspection results, there is a current focus on areas such as manual aseptic filling lines, poor root cause investigations and water systems