The US FDA told a recent meeting of the International Society for Pharmaceutical Engineering in Philadelphia that, even as the industry gets its data integrity issues on track, out-of-specification (OOS) investigations are on the rise. See what’s causing this trend, which is surfacing at both small labs and those with robust data integrity programs in place, learn the characteristics exhibited by top-performing laboratories, and glean important takeaways from related FDA warning letters in this informative article from Pink Sheet.