Source of the meningitis outbreak, New England Compounding Center was warned by their own people about issues in the production areas at the facility. Mold and bacteria was found and company officials turned a blind eye. The outbreak has caused 25 deaths across 18 states. Click below for more info.
Despite the warnings from its own monitors, the FDA report says the compounding center did not investigate the reports of the contamination nor is there documented evidence it worked to decontaminate the affected areas.
The FDA’s preliminary findings were released following an inspection of the compounding center this month. In addition to documented reports of bacterial contamination, FDA investigators observed “greenish black foreign matter” and “white filamentous material” in vials of methylprednisolone acetate — the steroid linked to the meningitis outbreak.
The Framingham, Massachusetts-based compounding center acknowledged receiving the report Friday, but declined to comment beyond saying it will review the findings.
