WASHINGTON — The National Institutes of Health has suspended operations at two of its facilities involved in clinical research trials after a probe last year identified serious contamination problems.
A National Cancer Institute laboratory producing cell therapies and a National Institute of Mental Health facility producing materials for a radioactive tracer test were found to not be in compliance with NIH’s quality and safety standards, the agency announced Tuesday. Production at those facilities has therefore been halted.
The NIH ordered a comprehensive review of all its production facilities, the preliminary results of which led to the suspensions announced Tuesday, after the discovery last year of contamination at the NIH Clinical Center’s Pharmaceutical Development Section.
Last summer, the agency announced it was suspending some operations at the clinical center because a Food and Drug Administration review, prompted by a complaint, had found contamination problems. In particular, two vials of a solution used in experimental trials were found to be contaminated with a fungus.
The broader review followed. The agency said Tuesday that there was no evidence that patients had been harmed as a result of the issues at the NCI lab or NIMH facility.
Vials from the same batch as the contaminated solutions found last year had been administered to six patients. However, the agency said Tuesday that there was no evidence that patients had been harmed.
A clinical review is underway, nonetheless, the NIH said, and the agency will not enroll new patients in any of the affected trials until the problem is resolved.
