FDA warns Genetech over Stem Cell Contamination

Liveyon recalls all Genetech Products

(Jan. 2, 2019)  The FDA warned Genetech, Inc. and its president Edwin N. Pinos on Dec. 20, 2018 for marketing stem cell therapies without FDA approval.  The FDA warning letter said the company – based in San Diego, Calif. – also committed “significant deviations from current good tissue practice (CGTP) and current good manufacturing practice (CGMP) requirements, including some violations that may have led to microbial contamination, potentially causing serious blood infections in patients.”

The FDA letter said “Genetech processed umbilical cord blood into unapproved human cellular products” distributed by Liveyon, LLC.

Dangerous, Unapproved Stem Cell Products

The FDA warning also put other stem cell providers on notice.  It was pointedly titled:  “FDA sends warning to company for marketing dangerous unapproved stem cell products that put patients at risk and puts other stem cell firms, providers on notice.”

In September 2018, Liveyon suspended shipment of all product pending an FDA inquiry into the source of adverse reactions reported last year.  Liveyon also recalled all Genetech products it may have distributed.

E.coli Stem Cell Contamination

The recall came too late for some.  FDA reported on Dec. 20 that at least 12 people have suffered bacterial infections from contaminated stem cell therapy.  FDA said it was aware of a dozen patients who had received Genetech products from Liveyon and subsequently became ill due to blood and other infections caused by a number of bacteria, including Escherichia coli (E. coli).

The FDA and the CDC have both received “numerous reports of safety issues including those involving microbial contamination,” according to the FDA’s Dec. 20 warning letter.

The infections FDA found were described in a Morbidity and Mortality Weekly Report (MMWR) titled “Notes from the Field:  Bloodstream Joint Infections in Patients after Receiving Bacterially Contaminated Umbilical Cord Blood-derived Stem Cell Products for Non-hematopoietic Conditions – United States, 2018.”

Significant Deviations

The FDA said that during its inspection it documented evidence of “significant deviations” from CGTP and CGMP requirements in the manufacture of the umbilical cord blood-derived products.  Those deviations included:

  • Deficient donor eligibility practices
  • Unvalidated manufacturing processes
  • Uncontrolled environment
  • Lack of control over components used in production
  • A lack of defined areas or a control system to prevent contamination and mix-ups

The FDA requested a response from Genetech within 15 working days of the letter’s release.  (That would be on or around Jan. 4, 2018). The response letter should detail how the deviations noted in the warning letter will be corrected.  FDA said deviations not corrected by companies and owners can lead to enforcement action such as seizure, injunction, or prosecution.

FDA:  Report Adverse Events

The FDA warning letter also said health care professionals and consumers should report any adverse events related to treatments with the Liveyon products, Genetech products, or other stem cell treatments.

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