When the Food and Drug Administration (FDA) inspected the pharmacy company that manufactured a contaminated medicine linked to 25 deaths, what it found would make your stomach turn.
Some 83 out of 321 vials contained “what appeared to be a greenish foreign matter,” the FDA said in an eight-page report late last week. Seventeen vials from that bin contained “what appeared to be white filamentous material.” One vial had a fungus.
There was bacteria and mold in a supposedly sterile room where drugs were made. And the air conditioner was put off at night, despite the fact that temperature and humidity were supposed to be carefully controlled at the facility.
The New York Times did a Page One story Saturday based on the FDA’s report , called a “483,” on its inspection of the New England Compounding Center (NECC) in Farmingham, Mass. This is the company that manufactured the tainted steroid, injected as a pain killer, that allegedly caused a national outbreak of fungal meningitis. Two dozen are dead, more than 300 are sick and possibly 14,000 were exposed to the steroid, according to The Times.
“The FDA observed and has since confirmed contaminated products and listed a number of observations regarding conditions in the clean room at NECC’s Framingham, Mass., facility,” the federal agency said in a press release.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm325994.htm
“The investigators also observed problems with NECC’s ability to maintain its clean room, which is the enclosed space that is designed and maintained to have a controlled environment with low levels of airborne particles and surface contamination,” the FDA said.
“Production of sterile drug products in a properly functioning and maintained clean room reduces the risk of the introduction of microbial contamination into the drug during processing, including filling into its final container.”
Finally, the press release said, “The FDA issues a 483 at the end of an inspection when the investigators believe that they observed conditions or practices that, in their judgment, may indicate violations of the Federal Food, Drug, and Cosmetic Act, or related regulations. The 483 does not constitute a final FDA determination that any observation listed on the 483 is a violation of the Federal Food, Drug, and Cosmetic Act or any related regulations.”
I think it’s a pretty safe bet that the FDA will ultimately there were violations by NECC, don’t you?
The FDA said it was continuing to work the U.S. Centers for Disease Control and Prevention and state partners, including the Massachusetts Board of Registration in Pharmacy, to investigate the outbreak of fungal meningitis among patients who received NECC’s compounded preservative-free methylprednisolone acetate, an injectable steroid.
The problem with compounding centers such as NECC is that they have essentially not been regulated by the FDA, since they are not full-fledged drug makers. As The Times pointed out in its Saturday story about NECC, “Instead of producing tailor-made drugs for individual patients, as the law allowed, the company turned into a major drug maker that supplied some of the most prestigious hospitals in the country.”
The FDA report also noted that NECC “is abutted to the rear and along the left parking area by a recycling facility that handles such materials as mattresses and plastics … the area was observed to include large equipment (e.g. excavators and freight trucks) producing airborne particulates (e.g. dust). Rooftop units serving the firm’s HVAC system were estimated to be located approximately 100 feet from the recycling facility.”
What did some of the experts say about this mess?
A pharmaceutical sterility expert, Russell Madsen, when asked about the FDA’s inspection report told The Times, “In all my time in the pharmaceutical industry, which is 45 years, I’ve never seen one this bad.”
