And, the company did not assess whether products made in the rooms on the days samples were taken could have become contaminated.
According to the FDA report, every one of the 62 surface samples taken in two clean rooms contained bacteria or mold, and more than half exceeded the action level.
By comparison, New England Compounding’s report to customers stated that between January and June, there was no contamination found on surfaces in the clean rooms that was outside the norm — what the company called an “excursion rate.”
It reported a 0.25 percent excursion rate for air monitoring in the clean rooms. The FDA report said the company’s internal documents showed two of five air samples taken during the same period exceeded the action level, or 40 percent.
The company’s customer report also stated that its “media fill success rate” — routine tests that certify staffers are correctly preparing sterile medications — found 100 percent success.
New England Compounding “has established an extensive environmental monitoring program for surface and air samples for clean room areas to ensure preparations are compounded in the cleanest environment possible and to document compliance with [industry] requirements,” the company’s report card stated.
Eric Kastango, president of Clinical IQ, a New Jersey-based pharmacist and safety consultant to the industry, said he has found that health care organizations often don’t know what questions to ask compounders to determine whether the companies are complying with industry standards.
“If you have a nice glossy brochure, and you represent that you can fill a need with all the drug shortages, nobody really wants to ask the hard questions,” he said. “You are led to believe by these vendors they are legitimate, but it’s not really independently vetted out.”