NIH Suspends Production at Two Facilities Over Sterility Concerns

The National Institutes of Health has suspended production at two of its facilities following a contamination probe.

According to the agency, an investigation found that a National Cancer Institute laboratory conducting cell therapy production and a National Institute of Mental Health facility producing positron emission tomography materials were not in compliance with quality and safety standards.

The investigation was initiated in June 2015 after an FDA inspection of the NIH Clinical Center Pharmaceutical Development Section uncovered problems with facilities, equipment, procedures and training. The findings resulted in NIH’s closure of the section’s sterile production unit.

NIH said April 21 that there was no evidence of harm to patients, and it would not enroll any new patients in affected trials until the problems are resolved. — Michael Cipriano



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