Three stem cell treatment centers have been hit with an FDA warning letter critical of their recordkeeping and lack of required licenses for their clinical procedures.
Thomas A. Gionis, owner of the Irvine Stem Cell Treatment Center in Newport Beach, Calif.; the Miami Stem Cell Treatment Center in Boca Raton, Fla.; and the Manhattan Regenerative Medical Group, in New York, failed to have proper BLA or INDs for the center’s procedures, the FDA said in a Dec. 30, 2015, warning letter.
During the inspections — all of which were conducted in July through September of last year — investigators found that the centers failed to establish and follow appropriate written procedures to prevent microbiological contamination of supposed sterile drug products, used poor aseptic techniques, did not have appropriate laboratory testing and did not validate manufacturing processes and controls.
In addition, the FDA hit Gionis for not having established environmental monitoring programs at his facilities or procedures for handling complaints. For example, the Florida facility had received five complaints, but it failed to thoroughly investigate those complaints, which related to treatment of degenerative joint disease, neuromyelitis optica, dementia and Parkinson’s disease, the letter states.
The facilities also lacked a quality control unit to approve or reject components and drug products and to review production records.
In response to the FDA’s Form 483, Gionis said the New York facility had closed Oct. 20, 2015. The remaining centers also discontinued the previous “methodology” and required all workers to pass an NIH course on protecting human research. The company also says on its websites that it does not “utilize the addition of chemicals or enzymes” to produce adipose-derived stem cells, but remains “consistent with all FDA guidance relating to stem cell therapy.”
However, the FDA says Gioinis hasn’t provided any information about changes to the manufacturing process, and it “therefore cannot assess whether such changes are adequate” to address “serious deviations” from current good manufacturing practices and current good tissue practices.
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