Expert: Document Production Essential Part of Inspections

November 9, 2009
FDA investigators are cracking down on devicemakers that are not able to produce documents during inspections, Elizabeth Troll, a 25-year veteran of the industry, said at a recent FDAnews webinar. The opportunity to get a second chance to correct observations from inspections is more limited now, she said, because investigators have been clear in their expectations.
The GMP Letter