Brief: FDA Warns American Cryostem Of Deviations Related To Co's Stem Cell Product

American Cryostem

04/01/2018 16:14

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:  ID:nPn4zLmMba  
Further company coverage:  CRYO.PK  
 
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