Tainted steroids and unsanitary conditions were found by federal regulators during inspections this month at the drug manufacturing plant linked to U.S. meningitis outbreak that has killed 25 people.
The Food and Drug Administration found elevated levels of mold and bacteria in a clean room at New England Compounding Pharmacy in Framingham, Mass., the agency said Friday in a report. A clean room is an enclosed space that is supposed to have low levels of airborne particles and surface contamination, the agency said in a statement.
The FDA observed 83 of 321 vials of methylprednisolone acetate, the steroid linked to the meningitis illnesses, contained “greenish black foreign matter,” according to the report, known as a 483. Seventeen vials from the same bin contained “white filamentous material.”
“The FDA issues a 483 at the end of an inspection when the investigators believe that they observed conditions or practices that, in their judgment, may indicate violations of the Federal Food, Drug, and Cosmetic Act, or related regulations,” the agency said in the statement.
Meningitis infections connected to the tainted medicine, used as an injection to relieve back and neck pain, have been reported by 338 people in 18 states, the Centers for Disease Control and Prevention said today on its website.
New England Compounding Pharmacy Inc., which used the name New England Compounding Center, or NECC, suspended operations this month and recalled more than 17,000 doses of the steroid after state and federal regulators began to link the company’s product to meningitis infections. The company sold the drug to at least 75 hospitals and clinics in 23 states.
Meningitis is an inflammation of the lining of the brain and spinal cord.
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