American Elephants

It’s All Falling Apart. Chapter Six by The Elephant's Child
June 5, 2015, 4:36 pm
Filed under: Health Care, Regulation | Tags: ,

The National Institutes of Health Clinical Center was inspected by the Food and Drug Administration late last month and several quality problems were found, NIH disclosed on Thursday. The facility on NIH’s Bethesda campus, makes products for clinical research studies in hospitals and other facilities. It will be shuttered until  improvements can be made.

FDA inspectors found insects in two of the five clean room lighting areas last month. They found two vials of albumin, a human blood protein, contaminated with fungus. Vials from the same batch were administered to six patients, although it is unknown of those vials were contaminated. The six patients have been notified but have shown no evidence of infection or illness.

FDA inspectors found 17 quality problems at the facility, as well as three problems at a hospital pharmacy including not cleaning areas properly.

NIH Director Francis Collins said “This is a distressing and unacceptable situation.”

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