Investigators said they observed conditions or practices that might indicate violations of the Federal Food, Drug, and Cosmetic Act, or related regulations
(UPI) -- U.S. health officials said the compounding pharmacy causing 338 to be sick with meningitis or infections and 25 dead may have broken the law.
The U.S. Food and Drug Administration observed a number of observations regarding conditions in the clean room at the New England Compounding Center in Framingham, Mass., officials said.
The FDA's report said the investigators said they observed conditions or practices that, in their judgment, might indicate violations of the Federal Food, Drug, and Cosmetic Act, or related regulations.
"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," the FDA statement said.
The U.S. Centers for Disease Control and Prevention in Atlanta confirmed the fungus Exserohilum rostratum was detected in unopened vials of a preservative-free steroid -- methylprednisolone acetate -- produced at NECC.
About 17,000 doses of the steroid were shipped from NECC and an estimated 14,000 were used in treatment to ease back and joint pain. Patients have become ill about one to four weeks following the injection, but health officials said infections, meningitis and stroke appeared to occur within the first 42 days after receiving the injections -- estimated to be around Nov. 6. The CDC said the risk of serious complications was lower after that time period.
The CDC said Tennessee was the first state to identify the fungal meningitis and had 74 patients sickened and 10 deaths, followed by 82 cases in Michigan and five deaths; 43 cases and two deaths in Virginia; 43 cases in Indiana and three deaths; 19 cases and one death in Maryland; 19 cases and three deaths in Florida; nine cases in Minnesota; 11 cases in New Hampshire; 11 cases in Ohio; two cases in North Carolina and one death; 18 cases in New Jersey, and one case each in Idaho, New York, Illinois, Texas, Pennsylvania, Georgia and South Carolina.