Operations at Pharmaceutical Development Section suspended by NIH

The US National Institutes of Health (NIH) Clinical Center has suspended operations of its Pharmaceutical Development Section (PDS) due to the discovery of serious manufacturing problems and lack of compliance with standard operating procedures.

The NIH announced yesterday that, after receiving a complaint, US Food and Drug Administration representatives inspected the PDS in May and found deficiencies that will require the NIH Clinical Center to take corrective action at the facility which makes products for clinical research studies.

Operations of the Pharmaceutical Development Section have been suspended immediately and no products will be made or distributed until all problems are fully understood and corrected. Materials produced by the Section are being systematically tested for contamination.