US Stem Cell Inc (USRM)

[NoMoDo]

Not missing your point at all. I quoted your words exactly.

As to your next subject of dust ridden vent - there is a world of difference between surgical centers and a drug manufacturing facility. USRM states:

Our facility has demonstrated sterile surgical techniques as required by the medical boards. It is inappropriate and harmful to state that our clinic is not sterile as we are completely compliant with the regulations for surgical procedures including using individually wrapped disposable sterile supplies, sterile field prep, and more. The strict regulations mentioned in the warning letter required to manufacture drugs are not applied to clinics or hospitals. As a clinic performing a medical procedure, we have strict and appropriate protocols in place to prevent contamination and breach of sterility. We are following the exact protocols that are utilized at surgical centers and hospitals. As you know, these protocols are very different than what is required for GMP manufacturing facilities. We have never had an incidence of contamination and the statements that were made in your warning letter and press release are misleading and causing irreparable harm.

Yet, USRM, "Out of an abundance of caution," agreed to follow the 501(k) system - which includes a sterile lab, written procedures, a written system of handling complaints and a procedure to determine how and whether any complaints need to be reported to the FDA.

They became compliant when they said they will follow the FDA requests.