Reports of Contamination in MA Pharmacy

By Caitlin O’Beirne

The United States Food and Drug Administration reported finding mold in the Framingham pharmacy linked to a deadly fungal meningitis outbreak.

83 vials of the steroid at the New England Compounding Center in Framingham had “greenish black foreign matter” said the FDA. They also reported 17 of the vials contained white fibers.

The FDA filed a 483 form saying conditions in the pharmacy may violate federal law. The report says New England Compounding did not conduct proper sterility testing on the steroid and did not use sterile ingredients.

The now-closed pharmacy released a statement Friday afternoon saying, “We will review this report and will continue our cooperation with the FDA. We will follow the existing regulatory process and provide our comments to the FDA after we have had adequate time for a complete review of the report.”

The pharmacy reported mold and bacteria above safety levels between January and September of this year, but FDA inspectors found no corrections or investigations into the contamination.

The FDA visited the pharmacy seven times throughout the month of October, after the steroid was recalled. Last week, the FDA confirmed a black fungus found in vials of the steroid in the New England Compounding Center was the same fungus causing the meningitis.

The steroid called methlyprednisolone acetate was administered to 14,000 people to treat back pain. People that received injections of the steroid are at risk for illness. The black mold has never been known to cause meningitis prior to this outbreak.

Dr. Arturo Casadevall told Sci-Tech Today reporters, “What we’re dealing with here is fundamentally different. This is a bug that most of us don’t know much about.”

The only way to detect the meningitis early is through a spinal tap. Treatment for the disease can take three months.

338 people have been infected and 25 people have died, according to US Centers for Disease Control and Prevention.

This past Tuesday a state inspection reported similar results to the FDA’s findings including contamination near the “clean room” and dirty equipment.

Image Courtesy: AP Images