FDA warning on sale of unapproved stem cell product

The US Food and Drug Administration (FDA) has issued a warning to American CryoStem Corporation (OTCMKTS: CRYO) for marketing an adipose derived stem cell product without FDA approval and for significant deviations from current Good Manufacturing Practice (GMP), including some that risk patient safety.

The New Jersey-based company calls itself a leading developer, manufacturer, and marketer of life-enhancing stem cell technologies in the field of personalized, regenerative medicine.

An FDA inspection found that it was receiving and processing adipose tissue into a product called Atcell and then marketing it without the required FDA approval.