Drug Maker Had Warnings Months Before Fungal Meningitis Outbreak
The company responsible for a deadly fungal meningitis outbreak was warned by its environmental monitors of bacterial contamination months before the outbreak began, according to a government report released on Friday.
Mold and bacteria were discovered in two separate areas at the New England Compounding Center’s two “clean rooms” almost 90 times since January, reports CNN.
The finding was released by the Food and Drug Administration, who is helping lead the investigation into the outbreak. Clean rooms are supposed to be sterile environments where drugs are produced.
The FDA report adds that, despite numerous warnings from its monitors, the pharmaceutical company didn’t investigate the reports of the contamination, nor is there any documented evidence that the company worked to decontaminate the affected areas.
Tainted medications from the New England Compounding Center have been blamed for 338 cases of fungal meningitis, which have caused 25 deaths so far, notes Newser.
FDA investigators released their preliminary findings after inspecting the compounding center this month. Along with finding documented reports of bacterial contamination, they also observed “greenish black foreign matter” and “white filamentous material” in the injections linked to the meningitis outbreak.
The company has declined to comment until after they review the findings. They released a statement Friday saying:
“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 FDA report was released the same week as the Massachusetts Board of Registration in Pharmacy voted to permanently revoke the compounding center’s license to operate in the state. They also revoked the licenses of the company’s three principal pharmacists.
The FDA has also confirmed that the black fungus discovered in the tainted steroid injections is the same fungus that caused the meningitis outbreak.
A damning nine-page report was also released by the Massachusetts Board of Registration on Tuesday, in which they state they “identified serious deficiencies and significant violations of pharmacy law and regulations that clearly placed the public’s health at risk.”
Federal authorities have also launched a criminal investigation into the center’s safety practices after the fungal meningitis outbreak.