FDA warns firm for selling unapproved stem cell products and GMP, GTP deviations

The US Food and Drug Administration (FDA) on 2 February warned an Idaho-based firm, Smart Surgical, dba Burst Biologics, for marketing and distributing allogeneic stem cell products for unapproved uses and for “significant” deviations from current good manufacturing practice (CGMP) and good tissue practice (CGTP) requirements.

The warning letter, which was posted to FDA’s website this week, follows an inspection conducted one year ago, just months before the agency ended its enforcement discretion policy against companies marketing unapproved human cells, tissues, or cellular or tissue-based products (HCT/Ps). (RELATED: Time’s up for questionable cell and tissue products, says Marks, Regulatory Focus 22 April 2021)

The warning letter concerns Smart Surgical’s marketing of products derived from human umbilical cord blood for allogeneic use, which are distributed to healthcare providers and facilities around the country. The products are “purported to be sterile” and are administered via intra-articular injection. The company’s website says these products are intended for spinal fusion and to treat foot and ankle disorders.

FDA said that company’s products do not meet the exception criteria for HCT/Ps laid out in 21 CFR 1271.10(a) and the criteria under 21 CFR 1271.15, and thus do not qualify for regulation solely under section 361 of the Public Health Service Act. As such, FDA said the firm’s products are “subject to additional regulation, including appropriate premarket review.” Yet the firm did not submit an investigational new drug application (IND) or a biologics license application (BLA) for any of the offending products.

FDA investigators said the firm’s GMPs and GTP violations included deficient donor screening, inadequate aseptic practices, unvalidated manufacturing processes, and deficient environmental monitoring.

“The deviations in manufacturing observed, as well as those noted in documented collected during the inspection, indicated that the use of your products raises potential significant safety concerns,” said FDA.

For example, the firm failed to effectively screen donors for the Zika virus. In May 2016, the firm began receiving umbilical cord blood units from allogenic donors in an area considered at a higher risk or Zika transmission, yet “failed to determine these donors as ineligible.” Products manufactured from those donations were distributed across the country.

Also, prior to 31 October 2019, the company failed to conduct media fill simulations to validate that the aseptic manufacturing process can “consistently produce products free of viable microorganisms.”

FDA officials last year voiced their disappointment with the slow uptake from companies seeking regulatory approvals to market and distribute stem cell therapies and that the agency was stepping up their enforcement against violative products. (RELATED: FDA disappointed with slow uptake of approvals for stem cell therapies, Regulatory Focus, 9 June 2021)

Warning letter

FDA warns firm for selling unapproved stem cell products and GMP, GTP deviations

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