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新 聞 及 資 訊   The United States: FDA sends warning to companies for offering unapproved umbilical cord blood products (PURE and PURE PRO by Liveyon) that may put patients at risk (English Only)   The United States Food and Drug Administration (FDA) announces that it has warned Liveyon Labs Inc. (Liveyon Labs) and Liveyon LLC, of Yorba Linda, California, and their presidents and chief executive officers, Roya Panah and John W. Kosolcharoen, for processing and distributing unapproved products derived from umbilical cord blood. They have also been warned regarding significant deviations from current good tissue practice (CGTP) and current good manufacturing practice (CGMP) requirements, including deficient donor eligibility practices, inadequate aseptic practices to prevent contamination and deficient environmental monitoring. These deviations create potential significant safety concerns that put patients at risk. The companies’ unapproved products derived from umbilical cord blood are PURE and PURE PRO. In addition to the warning letter issued to Liveyon Labs and Liveyon LLC earlier this month, the FDA sent untitled letters to RichSource Stem Cells, Inc., and Chara Biologics, Inc., for offering unapproved stem cell products to patients. The agency also recently sent 20 letters to manufacturers and health care providers noting that it has come to our attention that they may be offering unapproved stem cell products, reiterating the FDA’s compliance and enforcement policy. An FDA inspection of the Liveyon Labs and Liveyon LLC facility in May revealed the companies were processing and distributing products derived from human umbilical cord blood for use in patients who were unrelated to the donors. Because these products are not intended for homologous use only (i.e., to perform the same basic function or functions in the recipient as in the donor) and fail to meet other criteria set forth in applicable FDA regulations, they are regulated as both drugs and biological products. Therefore, to lawfully market these products, an approved biologics license application is needed. While in the development stage, the products may be used in humans only if an investigational new drug application (IND) is in effect. However, no such licenses or INDs exist for the PURE and PURE PRO products marketed by Liveyon Labs and Liveyon LLC. During the inspection, the FDA documented evidence of significant deviations from CGTP and CGMP requirements in the manufacture of the PURE and PURE PRO products, including deficient donor eligibility practices, such as failing to screen donors’ relevant medical records for risk factors for communicable diseases; inadequate aseptic practices, such as failing to follow procedures to prevent microbiological contamination; and deficient environmental monitoring, such as failing to establish a system for cleaning and disinfecting the processing room and equipment. These deviations pose a significant risk that the products may be contaminated with viruses or other microorganisms or have other serious product quality defects, which could potentially lead to patient harm. The FDA requested a response from Liveyon Labs and Liveyon LLC within 15 working days of the letter’s issuance that details how the deviations noted in the warning letter will be corrected. Deviations not corrected by the companies and responsible individuals could lead to enforcement action such as seizure, injunction or prosecution. Health care professionals and consumers should report to the FDA any adverse events related to treatments with the PURE or PURE PRO products or other stem cell treatments. Please refer to the following website in FDA for details: http://www.fda.gov/news-events/press-announcements/fda-sends-warning-companies-offering-unapproved-umbilical-cord-blood-products-may-put-patients-risk In Hong Kong, the above products are not registered pharmaceutical products; and there is no registered pharmaceutical product that is manufactured by Liveyon Labs Inc. or Liveyon LLC. Related news was posted to the Drug Office website on 21 Dec 2018. Ends/ Saturday, December 7, 2019 Issued at HKT 15:15