New England Compounding Pharmacy Inc., the company linked to a U.S. meningitis outbreak, discovered elevated levels of mold and bacteria at its drug-making facility in January and didn’t act, regulators said.
When the contamination was found to have exceeded limits the pharmacy itself set for mold and bacteria, “no documented corrective actions were taken,” the Food and Drug Administration said in a preliminary report that cites company documents. The FDA’s investigators uncovered tainted steroids and unsanitary conditions during inspections that began Oct. 1 at the facility in Framingham, Massachusetts, the agency said.
“It wouldn’t be proper for us to characterize this firm beyond the factual observations at this time,” Howard Sklamberg, the FDA’s deputy associate commissioner for regulatory affairs, said yesterday on a call with reporters. “This is part of an investigation. A broader investigation is where an agency characterizes and draws conclusions.”
The pharmacy suspended operations Oct. 3 after state and federal regulators began to link one of its steroid products, methylprednisolone acetate, to fungal meningitis infections that have now killed 25 people. The company, which used the name New England Compounding Center, recalled more than 17,000 doses of the steroid sold to at least 75 hospitals and clinics in 23 states. The government has said about 14,000 people received shots of the steroid, which is injected into the spinal cavity to relieve neck and back pain.
Meningitis is an inflammation of the lining of the brain and spinal cord. Fungal infections connected to the medicine have been reported by 338 people in 18 states, the Centers for Disease Control and Prevention said today on its website.
During its inspection this month, the FDA found greenish yellow and tarnished discolorations on equipment and in areas where the steroid was mixed, according to the report, known as a 483. The agency also said 83 of 321 vials of the steroid appeared to contain “greenish black foreign matter.” 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 a statement.
The company is a compounding pharmacy, which is supposed to prepare individual prescriptions unavailable through regular avenues, such as those with a unique dosage. These pharmacies are regulated by state governments.
Massachusetts officials had released preliminary results of a state investigation Oct. 23, saying there was evidence that sterilizing procedures weren’t fully followed at the company’s facility. A leaking boiler was found adjacent to a clean room, and it was determined that compounded drugs weren’t labeled with patient-specific identifiers, according to the report.
The company received the FDA’s report and “will follow the existing regulatory process and provide our comments to the FDA after we have had adequate time for a complete review,” the pharmacy said in a statement.
New England Compounding Center conducted its own “environmental monitoring program” in two clean rooms that are supposed to reduce the risk of microbial contamination during drug processing and found elevated levels of mold and bacteria, the FDA said in its report. A clean room is an enclosed space that is supposed to have low levels of airborne particles and surface contamination, the agency said.
The area is supposed to maintain low humidity levels and appropriate temperatures, said Steven Lynn, director of manufacturing and product quality at the FDA Center for Drug Evaluation and Research’s Office of Compliance. Instead, the company turned off the air conditioning nightly from 8 p.m. to 5:30 a.m., according to the report.
The FDA tested 50 vials of the steroid from the bin of discolored doses and confirmed the presence of viable microbial growth in all of them.
The FDA conducted the investigation with the cooperation of Massachusetts authorities, Sklamberg said.