WebMD Health News
Daniel J. DeNoon
Louise Chang, MD
Oct. 26, 2012 -- "Greenish black foreign matter" in supposedly sterile drug vials. Germs growing in steroid vials supposedly tested for sterility. Mold growing in the "clean room" where drug vials were filled.
These are just some of the observations made during an FDA inspection of New England Compounding Center (NECC). The Massachusetts compounding pharmacy's products appear to be the source of the ongoing fungal meningitis outbreak.
As of today, there have been 331 cases of fungal meningitis and seven joint infections caused by tainted steroids made by NECC. So far, 25 people have died.
It's not a final report. In a news conference, FDA officials refused to draw any conclusions from the findings. But the observations made by the FDA's inspection team paint an unsettling picture.
Among the findings:
One of the safety steps used in drug making is to make sure the gloves worn by people in the clean room are sterile. After finishing a product, workers press their gloved fingers into a culture dish (called a touch plate) that can be tested for germs.
FDA tests found mold and or bacteria growing in touch plates from workers who had prepared products (low-dose Avastin, for example) not currently suspected of causing fungal infections.
Before the FDA takes any action, it will consider this inspection report in combination with a formal Establishment Inspection Report and other relevant data.
The inspection is "part of a broader investigation where the agency characterizes findings and draws conclusions," Howard Sklamberg, FDA deputy commissioner for regulatory affairs, said today at a news conference.
Sklamberg and other FDA officials repeatedly refused to answer reporters' questions about the implications of FDA inspection report. But he hinted that the FDA is deeply concerned.
"Manufacturers and compounding firms have a responsibility to manufacture quality drugs and to ensure there is not a breakdown in the manufacturing processes that causes contamination," he said.
SOURCES:FDA 483 report on NECC, Oct. 26, 2012.News release, FDA.FDA news teleconference, Oct. 26, 2012.
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