Replies to post #30057 on Grapefruit USA Inc (GPFT)

[Denunzio36]

I'm sure they have plenty of manufacturing capability - Just not at their facility. Wouldn't you think Dean is either ready to sell the crap out of this once approved, or has been aligning someone else to manufacture this product OR is exploring resources and capabilities to open a new plant to get things going to themselves?

You are correct in saying they don't have the capability in the space they are in OR with the current staff they have.

[eagleagain2002]

Repair and refurbishment by definition IS manufacturing. Machines are dis-assembled, parts repaired and/or replaced and re-assembled. The process if done correctly requires written procedures, documentation of work completed and a quality assurance system, all recognized aspects of a manufacturing operation.The point is that it may not be directly related to the 510K, the FDA would be foolish not to look at existing manufacturing capability during the approval process just to be certain they are dealing with a legitimate and capable company. Let's not spin something that IS, into something that isn't.