FDA: Mold seen in 83 vials of the steroid linked to fungal meningitis outbreak
The US Food and Drug Administration found visible mold inside the Framingham pharmacy at the center of the national fungal meningitis outbreak, including 83 vials from one lot of the tainted steroid used to treat back pain that contained “greenish black foreign matter.’’
An additional 17 vials in that bin of 321 vials of methylprednisolone acetate had white fibers floating in them during the inspection. FDA investigators visited New England Compounding Center over seven days between Oct. 1 and Oct. 26, which was after the steroid was recalled by the company.
Other vials from this lot had already been sent out to clinics around the country, to be used for back and joint injections, between Aug. 17 and Sept. 25.
The agency Friday afternoon released a form called a 483, which is issued at the end of an inspection when investigators believe that they have observed conditions or practices that may violate the federal law.
New England Compounding did not do proper sterility testing on the steroid, the report said, sending out just one vial from the entire lot for testing -- a vial that passed the test. But when the FDA tested 50 vials, it found contamination in all of them. Experts say a minimum of 20 should be tested under national guidelines.
The FDA also found greenish yellow or other discoloration inside autoclaves, which are used to sterilize vials, stoppers, and compounded drugs.
The company’s own environmental testing showed bacteria and mold in numerous spots in two “clean rooms” -- where sterile drugs are prepared -- at the pharmacy between January and September of this year that were above New England Compounding’s own “action limits.” But there is no evidence that the company investigated further or took corrective measures, the report said.
And, the company did not assess whether products made in the rooms on the days samples were taken could have become contaminated.
The FDA pointed out that the company’s own formula for making methylprednisolone acetate called for the use of sterile ingredients. But New England Compounding actually made the product from non-sterile bulk powder, and the company did not have documentation showing that the steam autoclave cycle it was using was effective at sterilizing these types of raw materials.
The agency noted that the compounding company is adjacent to a recycling plant, owned by the same family, that handles materials and plastics. Excavators and freight trucks on the site spewed dust into the air, and rooftop heating and air conditioning units on New England Compounding were only 100 feet from the recycling operations.
Dark and white material was found on portions of the heating and air-conditioning unit inside the pharmacy’s building, behind an autoclave used to sterilize methylprednisolone acetate.
New England Compounding released a statement Friday afternoon, saying, “We will review this report and will continue our cooperation with the FDA. We will follow the existing regulatory process and provide our comments to the FDA after we have had adequate time for a complete review of the report.”
The US Centers for Disease Control and Prevention Friday afternoon reported that the number of infected people in the outbreak grew to 338, including 331 cases of meningitis and seven joint infections. An additional death was reported, in Tennessee, bringing the total to 25.
The conditions observed by the FDA were similar to those found by state investigators and detailed on Tuesday.
State inspectors found dirty lab equipment, a leaking boiler near the pharmacy’s “clean room,” and records that showed the pharmacy failed to properly maintain important sterilization tools, Madeleine Biondolillo, director of the state Bureau of Health Care Safety and Quality.
Governor Deval Patrick said the state would immediately begin annual, unannounced inspections of the roughly 25 other compounding pharmacies in Massachusetts that prepare sterile injectable medications such as those directly linked to the outbreak.Liz Kowalczyk can be reached at firstname.lastname@example.org.