FDA: New Investigators to End Era of ‘Gotcha’ Inspections

Acknowledging an era of “gotcha” inspections at the FDA, Lori Lawless, acting supervisory consumer safety officer in the FDA’s Baltimore district office, says that era is giving way to a culture of transparency and cooperation as a new group of investigators is being trained. “I think that comes from an older generation where there was a ‘gotcha’ kind of inspection,” Lawless said at FDAnews’ Fifth Annual FDA Inspection Summit. “There was a perception where investigators felt, ‘I’m going to get promoted if I issue a certain number of citations.’ We are trying to change that.”
Devices & Diagnostics Letter