“NECC’s transparency in dealing with the board since inception in 1998 demonstrates its good-faith intention to operate in compliance with the requirements of its license,” Cirel said.
Besides possible state license violations, Biondolillo said the inspections also revealed “several health and safety deficiencies” at the NECC facility in Framingham, just west of Boston.
Three lots of steroids produced by the company are suspected in the outbreak, and the company shipped orders from those lots 13 times before receiving the results of its own tests to confirm those lots were sterile, Biondolillo said. Some medication was shipped as many as 11 days before the company received test results, she said.
Biondolillo also detailed signs of flawed sterilization procedures, including black specks of fungus in sealed vials of the steroids, which were returned to the company during a recall.
Investigators found the company didn’t sterilize its products long enough and didn’t adequately test whether its sterilization equipment was working, she said.
In addition, mats on which people wiped their shoes to remove contamination before entering a sterile environment were “visibly dirty and soiled with assorted debris,” she said. And a leaking boiler adjacent to a pharmacy clean room left an unsanitary pool of water around it and the adjacent walls, she said.
None of what’s been found is enough to definitively determine what caused the contamination, and the investigation is ongoing, Biondolillo said.
Meanwhile, Patrick’s moves to increase oversight at the state’s 25 compounding pharmacies have already started.
The first of the unannounced inspections, to take place at least annually, was done on Tuesday, health department spokesman Alec Loftus said. He wouldn’t give the inspected facility’s name and said the results are being reviewed.
Patrick said compounding pharmacies will now be required to file annual compliance reports that could help regulators determine if they are acting as manufacturers.
Associated Press reporter Bob Salsberg contributed to this report.