"Visible Fungus" Found In Steroid Samples
Inspectors describe conditions found in lab at center of meningitis outbreak.
Massachusetts state officials say they found unclean conditions including visible black specks of fungus in steroids made by a pharmacy linked to a deadly outbreak of meningitis.
Governor Deval Patrick said Tuesday the state has moved to revoke the license of the New England Compounding Center and three pharmacists.
"Those whose laboratory practices caused this outbreak should never practice pharmacy or manufacture in Massachusetts again," said Patrick.
Patrick announced tough sanctions against the Framingham compounding company, which is at the heart of the national meningitis outbreak which has caused 23 deaths and sickened more than 300 people.
"I want to announce that the board of pharmacy has voted permanently to revoke NECC's license to operate in Massachusetts as well as the licenses of the company's three principal pharmacists," said Patrick.
State officials say a preliminary investigation found that the New England Compounding Center has health-related deficiencies including not properly labeling its medicines and not making sure medicines and equipment were sterile.
Madeleine Biondolillo of the Massachusetts Department of Public Health said on Oct. 2 there was visible black particulate matter in several vials of drugs. The matter was later confirmed by the FDA to be fungal contaminate linked to the meningitis outbreak.
State officials acknowledged that the state board that regulates pharmacies did not impose even minor penalties for complaints against the compounding center, which go back several years.
Officials said there were only letters that dismissed the complaints, without any discipline.
Patrick was asked "why" in a press conference on Tuesday.
He said he is asking himself the same questions.
"In this administration we're going to take a different tact -- a much more rigorous tact because we've seen from what has happened with this meningitis outbreak just how grave those consequences can be," said Patrick.
Patrick said criminal investigation was launched. Patrick added there will be changes for the remaining compounding companies in Massachusetts, including unannounced visits by state regulators.