FDA Issues Warning Letter To Stem Cell Company For cGMP Violations

FDA Issues Warning Letter To Stem Cell Company For cGMP Violations

April 7th, 2022 // 5:51 pm @

FDA issued a warning letter last month to Smart Surgical DBA Burst Biologics for marketing and sending allogeneic stem cell items that are unapproved. The company also had major violations from cGMPs and good tissue practices (CGTP).

The FDA warning letter was posted to the agency’s site in February 2022. It follows an FDA inspection that was performed in 2021. This was only a few months before FDA stopped its enforcement discretion rules against firms that market unapproved human cells, and tissue-based products (HCT/Ps).

The agency warning letter focuses on the marketing practices of Smart Surgical for products it derived from umbilical cord blood for allogeneic purposes. These products are delivered to healthcare companies and facilities around the US.

The stem-cell-derived products are supposedly sterile and are given to patients by intra-articular injection. The firm’s website states that the products are designed for spinal fusion and also to treat ankle and foot conditions.

However, FDA noted that the firm’s products do not qualify for exception criteria for products considered HCT/Ps as stated in 21 CFR 12.71.10(a) and under the rules of 21 CFR 1271.15. So, they do not qualify under FDA regulations as laid out in section 361 of the Public Service Act.

FDA stated that the company’s products must follow other regulations which include premarket review. But the firm has failed to submit the required IND or investigational new drug application. It also did not submit a biologics license application or BLA for its products.

FDA auditors also said the company’s GTP and cGMP violations including improper donor screening, poor aseptic practices, deficient environmental monitoring, and invalidated manufacturing practices and processes.

The letter stated that cGMP deviations noted during the audit raised major safety issues. For instance, the company did not test donors for the Zika virus. In 2016, the company started getting umbilical cord blood from donors in a part of the country considered at a higher risk for the Zika virus. But these donors were not ruled ineligible.

Also, the company did not do media fill simulations that validate aseptic manufacturing processes.

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