A facility used to manufacture drugs for early-stage clinical trials has been shut down by the National Institutes of Health (NIH), after an inspection found problems with the plant’s aseptic production practices. The closure is part of a review of the NIH’s Clinical Center Pharmacy Department.
An inspection conducted by the US Food and Drug Administration (FDA) in 2015, found multiple current good manufacturing practice (cGMP) violations at both the Pharmaceutical Development Section (PDS), and the Intravenous Admixture Unit (IVAU). Following the inspection, The NIH ceased production in the PDS, but the government agency has recently decided the permanently close the department.
The NIH used the PDS to manufacture drugs for use in Phase I and Phase II clinical trials. An interim IVAU has been established, with the NIH planning to move into the facility in October of this year.
One month before the FDA inspection, two vials of albumin were identified as contaminated with fungus. While the contaminated albumin was administered to patients as part of an interleukin experimental trial, no adverse events were reported.
The NIH was quick to address the violations by ceasing sterile production in the PDS, and employing outside firms to assess operations. Francis Collins, the director of the NIH, even went so far as to establish a new Office of Research Support and Compliance in late 2015.
After completing Phase 1 of its review, the NIH decided to permanently close the PDS in May of this year. “Phase 2 reviews begin this month and will look at instrumentation qualification, standard operating procedures and training, under the oversight of the newly established NIH Office of Research Support and Compliance,” said a spokesperson for the NIH.
As of yet, there are no plans for the NIH to reestablish the PDS. The agency says they plan to outsource the drug products they used to manufacture in the unit.
The FDA’s inspection found less serious violations in the NIH’s IVAU. “By the end of this calendar year, we expect a new interim Intravenous Admixture Unit (IVAU) to be operational,” said an NIH spokesperson.