Shortly before a national fungal meningitis outbreak was linked to New England Compounding Center, the Framingham company sent customers a “Quality Assurance Report Card” trumpeting the cleanliness of its labs, even as internal tests showed widespread contamination.
Charts sent to customers and obtained by the Globe show that in the first half of 2012, there were no instances of contamination exceeding the accepted standard on surfaces in the “clean rooms,” where the company produced sterile injectable medications such as the steroid now linked to 28 deaths.
But during that same period, the company’s own internal testing showed that 33 surface samples from the clean rooms contained bacteria or mold at levels requiring corrective action to remove contamination, according to company records. These test results were disclosed in a report released Friday by federal investigators.
Pharmacy and laboratory safety consultants said New England Compounding’s report card, sent to the Globe from a hospital that bought from the pharmacy, directly contradicts the findings of the company’s internal testing. The hospital provided the pharmacy report card on the condition it not be identified.
Three consultants who were shown the report card by the Globe said it lacks basic scientific data — such as how many tests were conducted to detect bacterial and mold contamination — that hospitals and other health facilities should have requested from the compounder to determine whether the company’s facility and products were up to the industry standards. They described it as a promotional brochure rather than a technical report.
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