NIH Drug Production Facility Found in Gross Violation of GMP

No one is above the law, including government run facilities. The National Institutes of Health (NIH) facility in Bethesda, Maryland, which manufactures injectable drugs for clinical trials being conducted at NIH hospitals with NIH funding, was found in violation of several GMP regulations by FDA’s inspectors. The
 deficiencies identified include albumin vials used for administering interleukin to be contaminated by fungus and several documentation errors during an FDA audit that spanned almost 10 days in May. According to the report, the facility has little or no arrangement to prevent contamination risks to sterile drugs, the ventilation system is faulty and quality control is inadequate. The FDA investigators found other gross quality violations as well including the practice of processing sterile drug products with exposed wrist skin by an employee, who had long and exposed facial hair. These deficiencies specifically applied to the sterile drugs and did not apply to non-sterile drugs; however, since the practices were linked to not following standard operating procedures (SOPs), lack of training, and poor facility design, the concerns raised have broader implication. FDA is reported to be quite concerned about the quality control issues detected at the center despite the NIH statement that the patients on whom vials were administered were being watched closely and no sign of infection was observed. Francis Collins, the NIH director
 reacted with concern and termed the situation as unacceptable and troubling. He assured FDA that he will personally look into the matter that is directly linked to the safety of patients. FDA has increased it enforcement of the drug manufacturing facilities following a similar incident in New England Compounding Center compounding center in 2012, where contamination led to fungal meningitis and killed 64 people. This incidence emphasizes the importance of training in SOPs and GMP for all personnel involved in handling, production, packaging, and dispensing of drugs used in clinical trials and healthcare.