On December 20, 2018, the Food and Drug Administration (FDA) issued a warning letter to Genetech Inc., citing numerous deviations from current good manufacturing and tissue practices. The compliance issues were discovered during a facility inspection between June 18 and June 22, 2018. The agency also found that the company was engaged in the manufacturing and distribution of umbilical cord blood products, which were not the subject of an approved biologics license application nor an investigational new drug (IND) application—thereby violating the Federal Food, Drug, and Cosmetic Act and Public Health Service Act.

The letter followed a recall of all ReGen Series products manufactured by Genetech, Inc. of San Diego, Calif., and distributed by Liveyon of Yorba Linda, Calif. On September 28, 2018, FDA’s Center for Biologics Research and Evaluation (CBER) notified the distributor of reports of possible adverse reactions. Liveyon subsequently suspended all shipments of the products while an investigation into reported adverse events was conducted by CBER. The agency worked with Liveyon on a strategic recall action plan and immediately initiated a voluntary recall of the products.

The FDA’s release on the recall and warning letters included a statement from FDA Commissioner Scott Gottlieb, MD, indicating an increase in the agency’s oversight of cell-based regenerative medicine. FDA offered a period of enforcement discretion after the guidance’s release, to allow time for manufacturers to file the necessary applications to be compliant with the new regulations.

Because of the rapidly changing regulatory environment for regenerative medicine products, it is imperative that surgeons are familiar with the regulatory status of any therapies they offer. A list of all currently approved cellular and gene therapy products is available on the FDA website.

Read the warning letter.