American Cryostem Corp (fka CRYO)

[236T568]

CRYO SUSPENDS all shipments of its products that failed to pass FDA approval

https://www.sec.gov/Archives/edgar/data/1468679/000101905618000336/acryo_1q18.htm

"On January 3, 2018 the Company received a warning letter from the FDA concerning our shipments of our ATCELL product within the US under our contract manufacturing agreement with Cells On Ice. The FDA states in the letter that they have determined that the ATCELL product is a drug and requires an active and approved Investigational New Drug Application to be filed with the FDA. Following review of the letter with the Company’s counsel and advisors and although the Agreement calls for Cells On Ice to be responsible for all FDA requirements, the Company has decided that due to the circumstances, to suspend shipment of the product under the Agreement until the requisite documents are filed and accepted by the FDA."


and here is the original warning press release issued by the FDA against CRYO:

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=138475929