The Massachusetts Department of Public Health has releases preliminary findings from its investigation into the New England Compounding Center, which is at the center of a fungal meningitis outbreak that has killed nearly two dozen individuals so far.
The investigation, which was initiated Sept. 26, reveals a number of shocking and serious safety deficiencies. They include:
• NECC distributed large batches of compounded sterile products directly to facilities apparently for general use rather than requiring a prescription for patients.
• Two different shipments of methylprednisolone acetate were delivered to providers before the NECC received final sterility test results in June and August.
• NECC failed to properly autoclave products to ensure product sterility.
• NECC failed to test their autoclaves to ensure proper function.
• Visible black particulate matter was found in several recalled vials of methylprednisolone acetate.
• Tacky mats, used to trap debris from shoes prior to clean room entry, were visibly soiled.
• A leaking boiler next to the clean room created a pool of water. Culture results from this pool are pending.
The health department's investigation is ongoing. The NECC, which is subject to regulatory sanctions, permanently lost its license.
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The investigation, which was initiated Sept. 26, reveals a number of shocking and serious safety deficiencies. They include:
• NECC distributed large batches of compounded sterile products directly to facilities apparently for general use rather than requiring a prescription for patients.
• Two different shipments of methylprednisolone acetate were delivered to providers before the NECC received final sterility test results in June and August.
• NECC failed to properly autoclave products to ensure product sterility.
• NECC failed to test their autoclaves to ensure proper function.
• Visible black particulate matter was found in several recalled vials of methylprednisolone acetate.
• Tacky mats, used to trap debris from shoes prior to clean room entry, were visibly soiled.
• A leaking boiler next to the clean room created a pool of water. Culture results from this pool are pending.
The health department's investigation is ongoing. The NECC, which is subject to regulatory sanctions, permanently lost its license.
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