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Regulatory Focus™ > News Articles > 11 > FDA Warns California Firm Over Unapproved Stem Cell Product, GMP Violations

FDA Warns California Firm Over Unapproved Stem Cell Product, GMP Violations

Posted 13 November 2018 | By Ana Mulero 

FDA Warns California Firm Over Unapproved Stem Cell Product, GMP Violations

StemGenex Biologic Laboratories drew a US Food and Drug Administration (FDA) warning letter over illegally marketing an unapproved stem cell product and serious good manufacturing practices (GMP) violations.

The violations include “some that could lead to microbial contamination,” which could in turn put patients’ health at risk, according to FDA. Agency investigators revealed 11 different violations at the firm’s facility in San Diego, following an FDA inspection conducted in January. The GMP violations include failures to follow procedures for preventing microbiological contamination of drug products purporting to be sterile, perform appropriate laboratory testing and establish a system for monitoring environmental conditions in the firm’s aseptic processing area.

The San Diego-based facility was further cited for not having a quality control unit from January 2012 through the time of FDA’s visit and inadequate procedures for handling written and oral complaints.

The warning letter also points to certain criteria that would have allowed the firm’s unapproved stromal vascular fraction (SVF) product to be exempt from having a valid biologics license in effect for this SVF product to have been lawfully marketed. “Such licenses are issued only after a showing of safety and efficacy for the product’s intended use,” the agency said.

In reaction to the cited violations, FDA Commissioner Scott Gottlieb argued Tuesday that “bad actors” are exploiting the scientific promise of regenerative medicine “to mislead vulnerable patients into believing they’re being give safe, effective treatments” and “also putting at risk the long-term viability of the industry and of effective products, when other operators are misleading consumers.”

The agency offered a new policy framework for regenerative medicine last November, Gottlieb noted. It is intended to encourage the development of clinically efficient new cell, stem cell and tissue products.

Meanwhile, the agency has been cracking down on producers of unapproved stem cell products that have been administrated to patients for treatments of certain ailments without sufficient scientific evidence to support their claims of clinical benefits. The agency called on the US Department of Justice in May to file injunctions against US Stem Cell Clinic and the California Stem Cell Treatment Center, seeking to cease marketing of unapproved stem cell and biological products that had been administered to patients.

StemGenex Biologic Laboratories, LLC 10/31/18


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