Grapefruit USA Inc (GPFT)

[eagleagain2002]

Sano, it could be zero production a year and they still could have well documented manufacturing procedures, a quality control system, a components traceability system, a purchase control system...all the things that make up good manufacturing practices. It makes good sense for the NEW FDA team to come in and review these manufacturing systems (not the actual machine assembly nor machine functionality) before they give full and final approval to the 510...don't you think? It is noteworthy they did this out of cycle, sure looks like a pre-approval move. No reason for them to come in now other than a final formality before approval. And its been reported in other places they passed with flying colors.