Unsanitary conditions and contaminated drugs at a firm that shipped medicines linked with a nationwide outbreak of fungal meningitis are documented in a U.S. Food and Drug Administration report.
On Saturday, 344 cases of fungal infection, including one in South Carolina, and 25 deaths were reported by the U.S. Centers for Disease Control and Prevention.
Most of the cases are fungal meningitis, an inflammation of the protective membranes covering the brain and spinal cord. Seven are infections in a joint such as a knee, hip or shoulder.
The steroid methylprednisolone acetate from New England Compounding Center has been linked to the infections, including a probable case of fungal meningitis in a patient who received a spinal injection of the drug at InterveneMD of North Charleston and Mount Pleasant.
In all of the fungal infections, the drug was injected either into the spine or a joint. Fungal meningitis is not contagious.
The eight-page inspection report posted Friday at the FDA website said 83 unopened vials of methylprednisolone acetate had a greenish-black foreign matter, and 17 unopened vials of the drug had a white filamentous contaminant.
Inspectors saw the contamination in a batch of the steroid that was later confirmed in lab tests to be tainted with a fungus. The suspect drug was shipped to customers between Aug. 17 and Sept. 25, the report states.
FDA inspectors observed other sanitation problems at the Framingham, Mass., firm. On Oct. 4, officials saw “greenish yellow discoloration” lining an interior surface of an autoclave used to disinfect various components and equipment used in the formulation of sterile drug products.
All of NECC’s products, including the tainted steroid, have been recalled. Massachusetts has moved to revoke the company’s license.
The firm is next to a recycling center that handles mattresses and plastics. On Oct. 2, inspectors saw excavators and freight trucks kicking up dust about 100 feet from the drug firm’s rooftop heating and cooling units.
Two days later, officials saw what appeared to be dark particulate and white filamentous substances covering louvers that are part of the heating, ventilation and air-conditioning system. The louvers are located behind an autoclave used for steam sterilization in the production of injectable methylprednisolone acetate.
FDA inspectors found a leaking boiler and wet floor with soiled debris 10 yards from a medicine prep room.
InterveneMD is the only health care facility in South Carolina that used methylprednisolone acetate from NECC, according to the CDC.
The medical practice reported that it has contacted 257 patients who received a spinal injection of the steroid, and 78 people who received an injection of the same product in a joint.
Historically, fungal meningitis has been a rare disease typically seen in people with a weak immune system. Bacterial and viral meningitis are more common.
Now, 14,000 patients nationwide are believed to be at risk of fungal meningitis because they received a spinal injection of the steroid after May 21.
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