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.
Notice the words 'DRUG PRODUCTS'.
Interpretation: Dr. LookGood can't explain to the FDA what he has concocted in the flow cytometer machine from Miilipore and how he has concocted them. In other words, 'snake oil in a syringe'.
Wouldn't you be better served getting some of those fat deposits removed from your arteries that are about ready to drop you? Sitting on you tail all day eating fat infested food spilled over you posting can't be good for you. Get out and exercise and eat healthy you lethargic lunk of #$%$. Those fat deposits have made it to your brain.
Angry and delusional - brokeback surfy is back. Back to the 'Denial' stage of Investor Grief? Or just bobbing up and down in the Doc's lap? Chin-platter, brokeback surfy - I didn't know the Doc had a lapdog named Roberto Martinez. LMAO