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,
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