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:
- In a bin holding 321 vials of methylprednisolone from the lots implicated in the outbreak, 83 vials contained "greenish black foreign matter" and 17 contained "white filamentous material."
- The NECC said its sampling showed that a batch of methylprednisolone was sterile. The FDA tested 50 vials from this lot and found living "microbial growth" in all 50.
- The so-called "clean room" where the NECC's sterile products were put into vials had mold and bacteria growing on many surfaces.
- The autoclave, a device that uses heated steam to sterilize products, had "greenish yellow discoloration" and "tarnished discoloration" on the inside.
- The NECC plant's heating and air intake is 100 feet from a recycling facility where heavy equipment throws up dust. "Dark particulate and white, filamentous substances" covered the air ducts behind one of the autoclaves used to sterilize products.
- There were puddles of water near a boiler close to the prep room where products were prepared. Wet floor surfaces "appeared to be soiled with thick white debris and thick black granular material."
- The air conditioner in the clean room is supposed to be on all the time to control humidity, temperature, and air pollution. But the NECC turned the clean room's A/C off at night.
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.
Inspection 'Part of a Broader Investigation'
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.