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Regulatory Focus™ > News Articles > 2019 > 9 > Stem Cells: FDA Warns Company for Selling Unapproved Products, Puts Others on Notice

Stem Cells: FDA Warns Company for Selling Unapproved Products, Puts Others on Notice

Posted 03 September 2019 | By Michael Mezher 

Stem Cells: FDA Warns Company for Selling Unapproved Products, Puts Others on Notice

The US Food and Drug Administration (FDA) last week warned San Juan Capistrano, CA based stem cell clinic Stemell, Inc over its sale of unapproved umbilical cord products and for good tissue practice (GTP) and good manufacturing practice (GMP) violations following a week-long inspection in March.
“Those who are manufacturing or marketing unapproved, potentially unsafe products must understand that there’s a clear line between appropriate development of these products and those practices that sidestep important statutory and regulatory controls that are in place to protect patients,” said Acting FDA Commissioner Ned Sharpless.
Alongside the warning letter to Stemell, FDA said it sent an additional 20 letters to manufactures and clinics offering unapproved stem cell products informing them of the agency’s compliance and enforcement policies for human cells, tissues, and cellular and tissue-based products (HCT/Ps).
“We remain very concerned that countless clinics across the country continue to market violative stem cell products to patients that have not been appropriately evaluated for safety or efficacy,” said Center for Biologics Evaluation and Research Director Peter Marks.
The actions come after FDA said it would step up its enforcement efforts towards stem cell clinics, which have long flown under the agency’s radar, last April.
Over the last year FDA has also warned other stem cell clinics and manufacturers, prevailed in a federal court case against Florida-based stem cell clinics and rolled out a temporary program to offer rapid, informal and nonbinding assessments to companies on how HCT/Ps will be regulated.
Warning Letter
According to the warning letter, Stemell manufactures and markets two stem cell-based products, StemL UCB-Plus and StemL UCT-Plus, for allogenic use that do not qualify for exceptions for HCT/Ps set out in 21 CFR 1271.15 as they are not intended for homologous use.
FDA also says that both products fail to meet other criteria set out in CFR 1271.10 for being regulated solely under Section 361 of the Public Health Service Act.
FDA points out that the firm referred to its products as “regenerative cellular therap[ies]” and are marketed to treat specific conditions such as arthritis. Stemell’s website also included a disclaimer stating that the company is a “supplier only” and that the company is “neither responsible nor liable for any medical claims by the physician or the clinic.”
FDA says that these disclaimers do not change the fact that Stemell’s products should be regulated as drugs and biologics.
The warning letter also details 11 citations for GTP and GMP violations, including failing to document donor eligibility determinations; failing to maintain donor screening procedures; process and laboratory controls issues; and lacking appropriate written procedures for validating aseptic and sterilization processes.
Statement, Warning Letter


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