Potential Regulatory Violations Uncovered at NECC Facility
Following weeks of reports about a meningitis outbreak affecting states across the entire country, the Food and Drug Administration is now reporting that the facility responsible may indeed have suffered from conditions that might constitute a potential regulatory violation.
This information was confirmed by way of a 483 form, which is filed by FDA investigators following an inspection that turns up a potential violation. In this case, inspectors were looking into the New England Compounding Center in Massachusetts. Steroids provided to patients throughout the nation by the NECC were found to be contaminated and likely led to a fungal meningitis outbreak that has thus far affected hundreds of citizens. It was this contamination that led inspectors to the site.
An investigation is being conducted by the Massachusetts Board of Registration in Pharmacy, the Centers for Disease Control and Prevention, and other state organizations as well as the FDA. It was inspectors at the FDA that identified deficiencies in the NECC’s efforts to keep their clean room free of a potential contamination threat. A clean room adequately taken care of can greatly limit the potential for a microbial contamination.
In addition, contaminated items were also identified at the facility. The FDA must now review this 483 report, in addition to other information such as company responses and an Establishment Inspection Report, before they take further action.
Consumers potentially affected by the steroids involved in the meningitis outbreak should stay abreast of the latest news as it happens.