A company with connections to the hospital drug supplier linked to a lethal meningitis outbreak is now under examination following a negative inspection report. The report comes from the Food and Drug Administration, which spent a month inspecting Ameridose, a Westborough, Mass.-based Company that has the same founders as the specialty pharmacy linked to a deadly meningitis outbreak.
The report reveals filthy, unsanitary conditions at the facility, as well as the presence of insects and wildlife such as birds.
The company said in a statement that, “While Ameridose’s history shows clearly that we have not had any instance of contaminated products over the course of the past six years, which covers the manufacture and shipment of 70 million units of product, and have always been guided by Good Manufacturing Practices (GMP) referenced in federal regulations, Ameridose is committed to addressing all observations in order to enhance our existing systems. We are in the process of preparing a full response for presentation to the FDA.”
Ameridose had willingly shut down for inspection a month ago following the release of tainted steroids by sister company New England Compounding Center.
The inspection’s results coincide with the release of additional information about The New England Compounding Center. The Boston Globe reports the center “disregarded sterility tests, prepared medicine in unsanitary conditions, and violated their pharmacy license.”
As of November, the fungal meningitis outbreak resulting from the drugs’ contamination has spread to 19 states and claimed 32 lives. Despite the New England Compounding Center shutting down its operations and issuing a voluntary recall, an additional 13,000 people injected with the methylprednisolone acetate steroid are at risk and could develop symptoms in the near future, according to Jamila Jones, a public affairs specialist for the CDC in Atlanta.