NanoViricides Inc. (NNVC)

[Deep6]

Manufacturing Facility #2
Just as another example of the "extra" time needed for medical (FDA approved) facilities....
I have supervised an assembly line that created gold refining equipment (think "Gold Rush")! The assembly line set-up went smoothly (rapidly), and we could make changes on the fly to meet customer requirements! Fun Job! Later, I set-up and supervised a medical device assembly line (what a nightmare)! The FDA would visit often and shut us down for just about anything they could find!! One of my procedures had pictures of how to assemble a medical device. The FDA auditor noticed that the current assembly tech was using the opposite hand to assemble the device (compared to the picture). This was because the assembler was "left handed". I had to either change the procedure to show assembly with either hand, or remove that tech from the assembly line and replace her with a right handed technician!! I KID YOU NOT!! I really have sympathy for NNVC as they head into these waters. Building that kind of facility and dealing with the FDA would not be worth the effort unless you were confident in your product. It it is just about ripping people off, there are MUCH easier ways to go about that!