FORM FDA 483 (09/08) (1st of 18 Observations) June 6, 2013
There are no written procedures for production and process controls designed to assure that the DRUG PRODUCTS have the identity, strength, quality and purity they purport or are represented to possess.
Specifically, a) during the Stromal Vascular Fraction manufacturing process (b)4 solution is added to the SVF process. Your procedure does not specify how this reagent is prepared and tested. b) Your firm manufactures a Stromal Vascular Fraction using (b)4. The stem cells are separated from adipose fat by centrifugation. However, there are no procedures in place and no documentation maintained showing validation and established working parameters for your Ultrasonic Processor.
Why don't you two just exchange email addresses and communicate that way? Just a quick browse of this mb shows that it's an ongoing and extremely annoying conversation between two people. There's no point in posting anything because the two of you will just start arguing about the same things you've been arguing about for months. We get it...you don't agree with each other and likely never will. Give it a rest and find something more productive to do with your time. I'll do the same by no longer browsing this board.
Quote: "HOWEVER, THERE ARE NO PROCEDURES IN PLACE AND NO DOCUMENTATION MAINTAINED SHOWING VALIDATION AND ESTABLISHED WORKING PARAMETERS FOR YOUR ULTRASONIC PROCESSOR" In other words, Point 53 of the lawsuit: "...intentionally false equipment calibration sequences prograrnmed by VICTOR, or at the direction of VICTOR, data was recovered and manipulated and otherwise falsified to obtain tissue test results which were presented in a false Iight where by ornission of material facts the test results provided expressly presented false positives for the presence of a 97% recovery of live cells in support of the claimed fraud."
More than just a 'claim' or a coincidence?
The thing that is so amazing and you will be faced with reality is there are patients that are posting on Facebook about their treatments and they not the variety that happen from a process that has not benefit. We are talking people that were in wheel chairs from auto crashes for years and years making remarkable progress. Not to mention heart studies and MS patients. You will have to sit through all that after you make what amount to vindictive claims that boarder on fraud. Not me, but many investors have probably lost money as a result of your work here on the boards.