番茄社区

to a company that makes stem cell and platelet-rich plasma products -- for pets.

The agency told Texas-based Safari Stem Cell that statements on and social media accounts show its products are intended to treat a variety of diseases and conditions in animals, but lack proper approval.

Safari Stem Cell claims its products can treat a range of diseases in pets, including arthritis, kidney disease, dry eye, and intervertebral disc disease, according to the warning letter. Its tissue- and cell-based products are derived from donated tissues from cats and dogs, FDA said.

However, those products should be considered animal drugs, which are subject to FDA regulation. However, the company doesn't have approval for them, nor does it have a "new animal drug application" approved to conduct research, the agency said.

During an inspection, FDA also discovered "significant deviations" from Current Good Manufacturing Practice (CGMP) regulations. These included failing to have written protocols to ensure quality of the products, failing to test for microorganisms, and failing to monitor environmental conditions in an aseptic area, according to the letter.

FDA said the company responded to an earlier notice about these violations in May 2023, which included a statement that it would cease operations. However, the warning letter was issued on April 5, 2024 after the company continued to promote and sell products on its website.

Steven Garner, the president of Safari Stem Cell, told 番茄社区 that the company has already made efforts to address the agency's concerns, including building a new CGMP compliant lab and updating the company's standard operating procedures and protocols.

"We were expecting most of the allegations and have addressed them," Garner said in an email. "We have been in operation for over 10 years with no notice from the FDA. We do have significant differences of opinion but are working with consultants on how to move forward."

Garner added that the company's goal is to "treat untreatable fatal diseases of pet animals in our hospital with stem cells," and he believes the company "should be able to continue this practice with proper client consent."

After receiving the FDA warning letter, Garner said the company sent a formal response to the agency. He added that the company is still awaiting a response from the FDA.

"Our initial response was sent within the required time frame and we set timelines for accomplishment of some of the tasks required. We have done these tasks but were awaiting a response from the FDA," he said.

The warning marks the latest efforts from the FDA to crack down on unapproved regenerative medicine therapies -- though it usually focuses on human products. Those products include various birth tissue products -- such as amniotic fluid or cord blood stem cells -- as well as other stem cell products.

The agency has been attempting to address noncompliant versions of these products . It now requires manufacturers of such products to meet premarket approval criteria, or conduct research under its investigational new drug requirements.

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