FDAnews
www.fdanews.com/articles/122283-inspection-prep-critical-for-combo-products

Inspection Prep Critical for Combo Products

November 17, 2009
Manufacturers of combination products should take extra care when preparing for FDA inspections — particularly foreign inspections, an expert says. “You get into strange situations, especially overseas, with companies that think they don’t need to meet GMPs at all,” Steven Kuwahara, founder of GXP BioTechnology, said at FDAnews’ Fourth Annual FDA Inspections Summit.
The GMP Letter