Many companies operate at risk because they don’t properly identify and manage risk or they are in denial that the consequences of performing at risk could jeopardize their entire business.
A perfect example is New England Compounding Center (NECC), where a nationwide outbreak of life-threatening fungal meningitis was traced back to steroids produced at this center. This outbreak has caused over 354 illnesses, including 25 deaths, in 19 states. A surprise inspection by the FDA discovered sterility issues which forced them to shut down the compounding center and recall all products.
In reviewing the agency reports, it’s clear to experts that NECC’s own business practices, or lack thereof, are most likely responsible for the contamination that has resulted in this outbreak. For example, approximately 24 reports have demonstrated that from January to September, the company’s own testing showed levels of bacteria and mold on clean room surfaces that exceeded the company’s own safety levels. This should have prompted immediate corrective action to current clean room procedures, but there is no evidence that such actions were taken.
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