Serious manufacturing issues found at Celltex facility

An FDA inspection report for Texas stem cell banking company Celltex includes a long list of manufacturing and lab problems, but the company says it is more a problem of language than cGMPs.

The 483 report says that during its April inspection at the Sugarland, TX, facility, the FDA discovered a lengthy list of issues, from failing to make sure the treatments produced there are sterile to labeling problems and whether the products contained the viable stem cells they are supposed to, reports in-Pharma Technologist. Inspectors found a bottle whose English-language label indicted it was a manufacturing reagent but it also had a Korean label that indicated it contained a cleaning or sanitizing product.

Celltex, which provides adult stem cell banking and multiplication services, previously has been criticized for allegedly providing adult stem cells for illegal use in humans. In March Bioethicist Glenn McGee resigned from his post at stem cell company after just three months. McGee, founder of The American Journal of Bioethics, took flak from his peers in the bioethics community over his taking the position at Celltex while still serving as an editor for the journal.

The company issued a statement last week that it has worked "closely with the FDA--both during its visit and since--to provide requested details and documentation to answer its questions," in-Pharma Tecnologist reports. "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."  

The company laid many of the problems off to the fact that the lab is run by its licensing partner RNL Bio with technicians and scientists from RNL's Seoul, Korea, headquarters, in-Pharma Technologist says.

- read the in-Pharma Technologist story
- here's the the FDA inspection report

Related Article:
Bioethicist quits job at controversial stem cell outfit