A Framingham pharmacy linked to a deadly meningitis outbreak sent customers a “report card” touting the cleanliness of its labs, even though internal tests showed widespread contamination.
Notable: Meningitis Outbreak
- 10/7/12: Mass. Pharmacy Linked To Meningitis Outbreak Issues Wide Recall
- 10/23: A Trail Of Complaints At Pharmacy Linked To Meningitis Deaths
- 11/7: Pharmacy Board Director Fired
- 11/14: Sec. Bigby: Outbreak A ‘Disaster’ That Was ‘Preventable’
- 12/21: Mass. Firm In Meningitis Case Files For Bankruptcy Protection
- 11/18/13: Congress Approves More Scrutiny For Compounding Pharmacies
- 7/10/14: Gov. Patrick Signs Compounding Pharmacy Bill
- 12/2: Proposed Fund For Meningitis Victims Upped To $135 Million
- 12/17: Pharmacy Owners Arrested
Complete Coverage: Meningitis Outbreak
The Boston Globe reports that a “Quality Assurance Report Card” sent to customers of New England Compounding Center claimed that during the first half of 2012 there were no instance of contamination exceeding accepted standards on surfaces in “clean rooms,” where the company produced sterile injectable medications.
But company records indicate that 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. Those results were disclosed in a report released Friday by federal investigators.
A company spokesman had no comment.
Three consultants who were shown the report card by the Globe described it as promotional material, rather than a scientific report. For instance, they said, it lacked basic scientific data, such as how many tests were conducted to detect bacterial and mold contamination.
“Their marketing material is baloney. They are just saying what they want to say,” said Stephen Runge, president of nanoCLEAN Decontamination Services, a Quincy company.
Contaminated steroids produced by NECC have been linked to a fungal meningitis outbreak that’s spread to 19 states, sickening more than 360, 28 of whom have died.
The company closed earlier this month, and state and federal investigators have since found evidence of unsanitary conditions there, including visible mold in 83 vials from one lot of the tainted steroid.
Two of the three lots of contaminated steroids were produced during the time covered in the company’s report card.