FDA and documentation requirements

The article below is from FDAnews; unfortunately the complete article is subscription-only. But the summary is clear enough, I think.


Expert: Document Production Essential Part of Inspections
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