NIH Stops Operations at its Pharmaceutical Development Section After Receiving Form 483
The NIH Clinical Center suspended operations of its Pharmaceutical Development Section, effective last week, due to serious manufacturing problems and lack of compliance with standard operating procedures discovered during an FDA investigation.
No products will be made or distributed until all problems are fully understood and corrected, NIH says. Materials produced by the facility are being systematically tested for contamination.
The FDA inspected the PDS from May 19 to 29, following an unspecified complaint, and found numerous deficiencies resulting in a 17-observation Form 483.
Investigators found flaws in the air filtering system, deficiencies in monitoring environmental conditions and cleaning sterile processing areas, buildings not being able to facilitate proper cleaning and not properly maintained and inadequate quality control. The facility also failed to maintain written records, ensure that protective apparel was worn, provide sufficient employee training and comply with standard operating procedures, the Form 483 says.
The PDS, which is located on NIH’s Bethesda, Md., campus, makes products for use in clinical research studies at NIH’s hospital and facilities.
In April, two vials of albumin — used when administrating interleukin in experimental studies — were discovered to have fungal contamination, according to NIH. Vials from the same batch were administered to six patients, but it’s not known whether those or other vials were contaminated. The six patients were notified and have been followed for signs of infection, the institute adds.
Roughly 250 participants in 46 other NIH studies are potentially affected, as they receive products manufactured by the PDS. NIH says it is working to secure alternative sources for those products, and that the vast majority of patients are not in immediate need of treatment.
NIH says it will appoint a group of microbiology and sterile manufacturing experts to conduct a thorough review of the entire operation and make recommendations to Director Francis Collins on corrective actions. An interim corrective action will be provided to the FDA by June 19.
Collins says he will personally oversee steps to remedy the situation as quickly as possible, calling the situation “distressing and unacceptable.”
The Form 483 is available at www.fdanews.com/06-05-15-NIH483.pdf. — Kellen Owings