Celltex Therapeutics is back in the FDA's doghouse. The agency hit the Sugar Land, TX, provider of stem cells with a warning letter containing a long list of regulatory and manufacturing violations, demanding swift action from the company to address the deficiencies.
The company, which has been accused of providing stem cells as therapies without proper licenses, was in the news in July after receiving a 483 notice from the FDA that described dozens of flaws or violations at its facility. At the time, Celltex issued a statement saying that it would work with U.S. regulators. But in the agency's Sept. 24 warning letter to the company, it appears that the regulator is less than satisfied with the way Celltex is conducting business and ensuring that its stem cells are sterile.
Now Celltex is under scrutiny at a time when the country is reeling from a meningitis outbreak linked with meds that were supposed to be sterile. Pharmalot reported on the FDA warning letter this morning and reminded readers of Celltex's relationship with a questionable South Korean stem cell outfit known as RNL Bio and how a letter from bioethics professor Leigh Turner of the University of Minnesota alerted U.S. regulators spurred the inspection.
In the Sept. 24 letter, the agency scolds Celltex for failing to put systems and procedures in place to prevent microbiological contamination of its products. Yet there are many alleged violations of good manufacturing practices (GMPs), including failure to validate aseptic manufacturing and gowning processes and establishing routine monitoring personnel.
Beyond manufacturing problems, Celltex faces some hurdles to satisfy the FDA's requirements for licensure of its stem cells, which the agency says are isolated from autologous adipose tissue (a fancy phrase for body fat) and then administered to patients for a variety of conditions. The FDA has decided that Celltex's method of processing the stem cells doesn't qualify for minimal manipulation for structural tissue, and the agency says the company has trialed its cellular remedies without an investigational new drug (IND) approval.
- here's the FDA's letter
- see Pharmalot's article
Correction: Leigh Turner, a bioethics professor from the University of Minnesota, was not an employee of Celltex. This article has been corrected.