New documents released by federal health officials detail the contaminated conditions found during an inspection of the compounding pharmacy at the heart of a national fungal meningitis outbreak, which has led to 25 deaths and sickened hundreds of people throughout the United States.
The FDA released a report (PDF) following the recent inspection of the New England Compounding Center (NECC) facility in Framingham, Massachusetts, confirming contaminated conditions at the compounding pharmacy that mixed the epidural steroid injections and other medications that have been linked to the fungal meningitis infections.
Problems were found throughout the facility, including the pharmacy’s clean room, which is a designated area where sterile drugs are produced. The clean room is designed to maintain a controlled environment, with low levels of airborne particles and surface contamination, to reduce the risk of microbial contamination during the processing of drugs.
Vials of methylprednisolone acetate, an epidural steroid injection used to treat back and joint pain, has been confirmed to be a source of the outbreak. Previously, the FDA and the U.S. Centers for Disease Control and Prevention (CDC) found the presence of exserohilum rostratum fungus in the steroid injections. The report confirms the vials contain greenish black foreign matter in some cases, and white filamentous material in others, confirming “the presence of viable microbial growth.”
The FDA’s form also indicates that there were prior problems at the compounding pharmacy with the ability to maintain a clean room. Bacteria and mold were found in two clean rooms during inspections between January 2012 and September 2012.
The inspection report, known as Form 483, is not a final determination of violation against the NECC. The FDA issues the form at the end of an inspection when conditions or practices that may indicate violations of the Federal, Food, Drug, and Cosmetic Act are observed.
The FDA will complete the inspection, consider Form 483, the Establishment Inspection Report (EIR) and responses from the company before determining if further action is required.
The fungal meningitis outbreak death toll has reached 25 and has spread to 18 states, mostly affecting the East coast; but spreading to Idaho, Texas, and Minnesota, according to latest U.S. Centers for Disease Control and Prevention (CDC) updates. Michigan and Tennessee have the highest concentration of infections with 82 and 74 cases, respectively. Michigan has reported five deaths and Tennessee ten.
The outbreak has 344 confirmed cases of meningitis linked to the tainted batch of epidural steroid injections. Seven of those cases are peripheral joint infections that mainly attack the elbows, hips, knees and ankles.
More than 17,500 doses of the infected steroid have been recalled. Officials estimate nearly 14,000 people may have received a dosage from the tainted batch. Health officials expect new cases to continue to surface through November and possibly past Thanksgiving as the scope of the contamination and incubation period continue to be monitored.