The US National Institutes of Health suspends operations at its pharmaceutical development section after FDA inspectors uncover serious manufacturing issues
The US National Institutes of Health (NIH) has suspended sterile manufacturing at its pharmaceutical development section (PDS), which makes products for clinical research studies conducted in the agency’s clinical centre and collaborating facilities. Inspectors from the US Food and Drug Administration (FDA) discovered ‘serious manufacturing problems and lack of compliance with standard operating procedures’ according to an NIH statement.
The halt could potentially affect 46 clinical trials, and about 250 patients who are either receiving, or about to receive, products manufactured at the facility. ‘We are searching for alternative sources for all of the products,’ says Lawrence Tabak, the NIH’s principal deputy director. He notes that some of these materials are available from sources outside of NIH, but some clinical trials might need to be delayed until other facilities can produce the products required.
FDA representatives inspected the PDS in May 2015, following a complaint. They uncovered a series of deficiencies, including fungal contamination in two vials of albumin from a batch used to administer the drug interleukin in experimental studies in April.
The NIH will conduct a thorough review and provide an interim corrective action plan to the FDA by 19 June.