Aggregated News
The Food and Drug Administration has informed the Sugar Land company involved in Gov. Rick Perry's adult stem-cell procedure that it is illegally marketing an unlicensed drug.
In a warning letter, the FDA gave Celltex Therapeutics Corp. 15 business days to submit a plan to address the agency's concerns, including correcting previously cited manufacturing problems. The letter said that failure to respond promptly could result in seizure or injunction by the FDA.
"Based on (our) information, your product violates the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act," says the letter, sent on Sept. 24 and publicly posted Tuesday.
The letter comes about six months after the FDA made a 10-day inspection of the facilities where Celltex banks and grows stem cells taken from prospective patients. The agency subsequently filed a report, obtained by the Chronicle in June, detailing dozens of manufacturing deficiencies, from incorrectly labeled products to failed sterility tests.
The new warning letter reiterates those problems and asks for more information about them.
David Eller, Celltex's CEO, was unavailable Tuesday, but a public relations...
In a warning letter, the FDA gave Celltex Therapeutics Corp. 15 business days to submit a plan to address the agency's concerns, including correcting previously cited manufacturing problems. The letter said that failure to respond promptly could result in seizure or injunction by the FDA.
"Based on (our) information, your product violates the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act," says the letter, sent on Sept. 24 and publicly posted Tuesday.
The letter comes about six months after the FDA made a 10-day inspection of the facilities where Celltex banks and grows stem cells taken from prospective patients. The agency subsequently filed a report, obtained by the Chronicle in June, detailing dozens of manufacturing deficiencies, from incorrectly labeled products to failed sterility tests.
The new warning letter reiterates those problems and asks for more information about them.
David Eller, Celltex's CEO, was unavailable Tuesday, but a public relations...