A contamination scare at the U.S. National Institutes of Health (NIH) Clinical Center resulted in operations being suspended at the facility on June 4.
Now the NIH has submitted interim corrective action plans to the U.S. Food and Drug Administration (FDA) to address problems with sterile manufacturing processes.
The actions are primarily focused on fixing problems in the Pharmaceutical Development Section (PDS), and deficiencies of lesser significance in its pharmacy. The issues were uncovered during an FDA inspection at the facility
“NIH takes this issue very seriously and senior leadership took swift action to ensure the safety of research participants,” said the NIH in a statement. “As corrective action is taken to remedy the situation, NIH will continue to take every measure to protect patients and provide access to needed treatments.”
As part of the plan, NIH will hire a contracting firm experienced in Current Good Manufacturing Practice (CGMP) regulations and procedures. The firm will provide a full evaluation of the PDS operations and make recommendations for improvement and for addressing all FDA concerns.
NIH will also establish an external group of advisors with expertise in CGMP-facility management, clinical research, engineering and regulatory requirements to consider the recommendations of the contractor and oversee the implementation of the corrective actions. The plan outlines an aggressive timeline to achieve key milestones by the end of September 2015.
The Clinical Center will not resume sterile products production until all observations are addressed and the facility is inspected by an independent organization to establish that the PDS can meet current cGMP standards and FDA agrees that production should resume.