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Unsanitary practices at pharmacy blamed in meningitis outbreak

Federal investigators 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, according to a report released Friday by the US Food and Drug Administration that depicts a plant where safety practices were lax and contaminants widespread.

Agency investigators visited New England Compounding Center over seven days this month, 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 company’s own environmental testing between January and September showed bacteria and mold in numerous spots in two “clean rooms” — where sterile drugs are prepared — 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 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 federal law.

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 contaminated steroids from the Massachusetts pharmacy have infected 338 people — 331 with meningitis and 7 with joint infections, the Centers for Disease Control and Prevention said Friday. Another death was reported in Tennessee, bringing the total to 25.


The FDA report also indicated that the firm did not do proper sterility testing on the tainted batch of steroids, 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. Specialists say that under national guidelines, a minimum of 20 should be tested.

Steven Richter, president of Microtest Laboratories in Agawam and a former FDA microbiologist, said he usually recommends clients test 40 vials for large batches.

Richter’s company manufactures drugs for biotechnology companies to use in clinical trials, and consults with compounding companies on proper drug-making practices.

“People will generally try to save money on testing and cut corners,” Richter said. “Plus you are losing the vial you can sell.’’ He said it would cost roughly $1,000 to test 40 vials for sterility.

He said New England Compounding should have taken action when its internal testing showed contaminants in the environment. “You have to shut the clean rooms down’’ and do in-depth cleaning, he said. A company then has to take more samples and possibly wait two to three weeks until it is sure the area is clean, which means lost revenue.

Jim Nahill, owner of Pallimed Pharmacy in Woburn, which does sterile compounding, said it is “extremely uncommon” for well-run companies to detect mold or bacteria in their clean rooms.


“In seven years we found it once,” Nahill said.

Nahill said his company, one of just four in Massachusetts accredited by the Pharmacy Compounding Accreditation Board, according to the agency’s website, has invested thousands of dollars on equipment to check for mold and bacteria in its sterile areas.

The FDA also found greenish-yellow or other discoloration inside New England Compounding’s autoclaves, which are used to sterilize vials, stoppers, and compounded drugs.

The report noted that New England Compounding staff members told inspectors that it shuts down the air conditioning in its clean rooms between 8 p.m. and 5:30 a.m. daily, which is something that is “not a typical practice,” said Steven Lynn, a director in the Office of Compliance of the Center for Drug Evaluation and Research.

Speaking to reporters during a conference call Friday, Lynn said “low humidity levels, appropriate temperatures, low levels of airborne particles, and frequent cleaning” are necessary to properly maintain clean rooms.

Nahill said routinely shutting off air conditioning could foster prime breeding grounds for contaminants that typically grow in warm, moist conditions. He said he leaves his fan and filtering systems on around the clock and shuts his air conditioning system down only on weekends, then strips the clean room and washes everything down Monday mornings.

Industry “guidelines suggest you do that once a month. We do it once a week,” Nahill said. “I like to sleep at night.”


The FDA pointed out that New England Compounding’s own formula for making methylprednisolone acetate called for the use of sterile ingredients. But the company 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.

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, said Madeleine Biondolillo, director of the state Bureau of Health Care Safety and Quality.

Governor Deval Patrick said Tuesday that 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.

Some of those compounders, anxious about the heightened scrutiny and potential new regulations, apparently have decided to stop production of sterile products, said an industry official. These include injections, intravenous solutions, and a drug used to stop the heart during surgery. They still would make nonsterile products, such as lotions, creams, or customized doses of off-the-shelf drugs.


Todd Brown, executive director of the Massachusetts Independent Pharmacists Association, a trade group that represents most compounders, said Friday he had heard that a couple of companies had decided to stop, but he had not yet spoken to them to confirm that information.

Nahill, the Woburn compounder, said he knew at least one company recently called it quits on sterile production because its customers started coming to his pharmacy.

Liz Kowalczyk can be reached at kowalczyk@globe.com. Kay Lazar can be reached at klazar
. Follow her on Twitter @GlobeKayLazar.