January 4, 2018 / 4:39 PM / 6 months ago

BRIEF-FDA Warns American Cryostem Of Deviations Related To Co's Stem Cell Product

Jan 4 (Reuters) - U.S. Food and Drug Administration:

* FDA WARNS AMERICAN CRYOSTEM CORPORATION OF SIGNIFICANT DEVIATIONS RELATED TO ITS UNAPPROVED STEM CELL PRODUCT, ATCELL

* U.S. FDA​ - POSTED WARNING LETTER ISSUED TO AMERICAN CRYOSTEM CORPORATION FOR MARKETING ADIPOSE DERIVED STEM CELL PRODUCT WITHOUT FDA APPROVAL

* U.S. FDA - RECENTLY INSPECTED AMERICAN CRYOSTEM & FOUND IT WAS PROCESSING ADIPOSE TISSUE INTO PRODUCT CALLED ATCELL, MARKETING IT WITHOUT APPROVAL

* U.S. FDA - UNDER FDA’S RISK-BASED ENFORCEMENT STRATEGY, ATCELL ALSO CREATES CONCERNS DUE TO THE WAY IT IS BEING ADMINISTERED INTO PATIENTS’ BODIES

* U.S. FDA - ATCELL ALSO CREATES CONCERNS DUE TO HOW IT IS PROMOTED FOR THE TREATMENT OF SERIOUS OR LIFE-THREATENING DISEASES OR CONDITIONS

* U.S. FDA - AMERICAN CRYOSTEM’S METHOD OF MANUFACTURING RISKS ATCELL POTENTIALLY BEING CONTAMINATED WITH MICROORGANISMS, OTHER QUALITY DEFECTS

* U.S. FDA - AMERICAN CRYOSTEM’S MANUFACTURING METHOD INCLUDED SPECIFIC DEVIATIONS SUCH AS UNVALIDATED PROCESSES & AN INADEQUATELY CONTROLLED ENVIRONMENT

* U.S. FDA - FDA HAS REQUESTED RESPONSE FROM AMERICAN CRYOSTEM WITHIN 15 WORKING DAYS DETAILING HOW VIOLATIONS NOTED IN WARNING LETTER WILL BE CORRECTED Source text for Eikon: Further company coverage:

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