Inspectors found "greenish-black foreign matter" in vials of supposedly sterile steroids meant for back pain injections at the Massachusetts company under investigation in connection with the nation's meningitis outbreak, the Food and Drug Administration said Friday.
"We call this 'overgrowth,' when they are very visible to the naked eye," said Steven Lynn, director of FDA's office of compliance at the Center for Drug Evaluation and Research.
The vials were observed at the New England Compounding Center of Framingham, Mass. The center is at the forefront of the FDA investigation into the meningitis outbreak, which has so far killed 25 people and sickened 338. An estimated 14,000 people are believed to have gotten tainted shots.
Investigators reviewed materials at the compounding center and saw 83 vials out of a bin of 331 containing the steroid implicated in the outbreak. These 83 vials contained "what appeared to be a greenish-black foreign matter," an FDA report said. Seventeen of those vials "were observed to contain what appeared to be white filamentous material."
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The firm's own environmental monitoring program showed bacteria and mold in two clean rooms at the production facility, the FDA reported. Clean rooms are specially designed to have low levels of contamination and keep out dust, airborne microbes and other particles. One way this is done is to filter air through air conditioning and filtering.
Staff reported to FDA that the firm shut off the air conditioning in the clean room every night from 8 p.m. to 5:30 a.m.
Although a sample taken by the firm to confirm that its product was sterile gave a sterile result, FDA analysis of the vials "confirmed the presence of viable microbial growth in 50" out of 50 vials tested.
NECC workshops stated that the raw materials they used were sterile. However, the NECC director of pharmacy told FDA inspectors that the firm used non-sterile active pharmaceutical ingredients to make injectable drugs, such as those linked to the outbreak.
The firm also had no documentation or evidence to support that its steam autoclave cycle, a machine used to sterilize drugs, was effective.
The inspection report released Friday is "a snapshot in time" and does not necessarily indicate ongoing conditions at the NECC production facility, Lynn said.
However, Paul Teitell, with FDA's Office of Regulatory Affairs, said that drug manufacturers have the responsibility to put out safe drugs and to have processes in place to ensure that breakdowns are caught.
"It's shocking" but not surprising given the level of regulation over this type of compounding pharmacy, said Victoria Richards, a professor of pharmacology at the school of medicine at Quinnipiac University in North Haven, Conn.
The company's own environmental monitoring program found bacteria and mold in two of its clean rooms at least 79 times between January and September, the FDA said. This included areas where sterile gowns, booties and other clothing were kept and a bin that held tamper-evidence caps.
The results were not investigated, and the firm did not identify the bacteria or molds found growing in its clean rooms, the FDA report said. No product-impact assessments were done for any of the sterile products made on the days the samples were taken.
"In addition, the firm has no evidence that any corrective actions were taken to prevent contamination of the sterile drug products," the FDA report said.
