Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
Thursday, January 4, 2018
FDA warns American CryoStem Corporation of significant deviations related to its unapproved stem cell product, Atcell
The U.S. Food and Drug Administration today posted a warning letter issued to American CryoStem Corporation of Monmouth Junction, New Jersey, and its Chairman/Chief Executive Officer, John S. Arnone, for marketing an adipose derived stem cell product without FDA approval and for significant deviations from current good manufacturing practice requirements, including some that raise potential significant safety concerns, putting patients at risk. Continue reading.