The head of a stem cell company has responded to a warning letter issued by the U.S. Food and Drug Administration citing several violations at the company which derives stem cells from adipose tissue or body fat.
Dr. Steven Victor of IntelliCell BioSciences said it would be moving to a new facility next month that it believes will address the current good manufacturing practice issues referred to in the warning letter It has also hired consultants with FDA compliance experience that will help bring its new facilities in compliance with the FDA. Victor added that the company will address all of the FDAs observations on April 3.
The New York company received a warning letter dated March 13 that was published on the FDAs website yesterday. The letter said that the process that the company uses to produce stem cells from adipose tissue did not meet the FDAs definition of minimal manipulation for structural tissue such as adipose tissue.
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CEO of stem cell company responds to FDA warning letter
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