The US FDA has published a 483 detailing the violations it observed during an inspection of stem cell firm Celltex Therapeutics in April and the document does not make for comfortable reading.
The agency visited Celltex’ cell bank and multiplication lab in Sugarland in April at the request of the Texan firm and uncovered numerous deviations from applicable standards, ranging from a failure to ensure that treatments produced there are sterile, properly labelled or even that they contain the viable stem cells they are supposed to.
Additionally, the inspection team noted that some batch and production records lacked key information, staff washrooms were poorly located and discovered that a bottle whose English language label indicted it was a manufacturing reagent also held a Korean label which suggested that it contained a cleaning or sanitizing product.
Celltex – which continues to offer a cell banking and multiplication service - has 15 days to address the Food and Drug Administration’s (FDA) observations. The firm was quick to respond to the findings.
In a statement last week it said: “Celltex has worked closely with the FDA — both during its visit and since — to provide requested details and documentation to answer its questions.
“We have resolved many of the FDA observations, and we are working to address the remainder. We have an open line of communication with the FDA and expect to maintain that in our cooperative relationship."
Celltex attributed many of the problems to a language barrier, pointing out that the lab is operated by its licensing partner RNL Bio with technicians and scientists from RNL's Seoul, Korea headquarters.
“RNL scientists extensively document procedures, including validations, but they are recorded in Korean and were not able to be provided in English to FDA during its visit.
“Since the FDA's visit, the RNL procedures and other documents have been translated to English by an independent, professional translation service, and supplied to the agency.”
Stymied stem cell support?
Whether Celltex will be able to fix its problems or if the FDA will seek legal a legal injunction against the firm - like it did after discovering similar manufacturing issues at fellow stem cell therapy company Regenerative Sciences LLC in 2010 - remains to be seen.
But even before this is decided the results of the inspection have attracted considerable media attention due to Celltex's high profile involvement with Texas Governor Rick Perry .
Last year the former US presidential hopeful and sometime stem cell technology supporter revealed that Celltex was involved in multiplying stem cells that were subsequently used to successfully treat his back pain.
However, some have suggested that since the 483 Perry has tried to distance himself from Celltex pointing to his response to an enquiry from the Houston Chronicle last week that the firm’s problems were “between the company and the FDA” as evidence.
One such observer is Paul Knoepfler an associate professor in Cell Biology and Human Anatomy at the UC Davis School of Medicine who blogs about stem cell therapy .
He suggested that: “The expectation of many was that Perry would publicly support Celltex. Most people thought that in his public response to the FDA audit that he would defend Celltex and perhaps indicate that Texas would not put up with federal intervention into Celltex’s business.”