The National Institutes of Health (NIH) Clinical Center has suspended operations of its Pharmaceutical Development Section (PDS) facility based on recent FDA 483s that were issued by FDA in May 2015. The facility makes products for certain clinical research studies conducted in the hospital and collaborating facilities. In April, two vials of albumin, used for the administration of the drug interleukin in experimental studies, were found to have fungal contamination after the batch was administered to patients.

Following the fungal contamination complaint, FDA inspected the National Institutes of Health manufacturing site in May of 2015. On June 4th, operations at the Pharmaceutical Development Section (PDS) at the NIH Clinical Center were suspended.

The recent FDA 483 issued to the PDS facility contained 17 detailed observations containing comments such as:

  • “Container closure integrity testing is not performed for any sterile drug products.”
  • “Insects were observed in two (2) of five (5) ISO 7 cleanroom ceiling light bays . . . .”
  • “There is no GMP training program . . . .”
  • “The quality unit is not involved in release of drug products . . . .”

The 483 issued to the NIH brings up several questions – some of which may not be able to be answered due to NIH’s lack of an effective monitoring process.

Who’s in charge of clinical trial manufacturing? How long has NIH been in noncompliance with the basic principles of cGMPs and aseptic processing? How many clinical trial subjects are at risk? What would have happened if this letter was received by a for-profit pharma company?

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