Ex-workers: Company linked to meningitis outbreak had questionable practices
The deadly outbreak of meningitis has spread to 16 states and infected 271 people. Today, the death toll climbed to 21.
The outbreak has been linked to steroids made at a specialty pharmacy in Massachusetts.
According to state records, from the day the New England Compounding Center (NECC) opened in 1998 to the day it voluntary shut down, the company was inspected nine times by the state and federal regulators.
An inspection of the facility by the Food and Drug Administration prompted a 2006 enforcement letter warning that some of their procedures could lead to "potential microbial contamination.
"Well it's clear the company made a conscious effort to disregard that warning letter because only a few years later they were engaged in the very behavior the FDA warned them about," Sheldon Bradshaw, the former chief counsel of the FDA who signed the warning letter to the NECC, said.
CBS News talked to a number of former employees who didn't want to be identified. Some praised the company's safe guards. Others told us they saw incidents were safety was sacrificed.
One former employee told us they witnessed NECC technicians handling drug vials without hair nets or gloves. Another former employee said the company's owners debated as far back as 2009 whether NECC had crossed the line from compounding, which involves mixing approved drugs for individual prescriptions -- which is allowed -- to manufacturing, which would require more oversight.
"These large drug manufacturers who operate under the guise of traditional pharmacy compounding are clearly violating the law, and they do so because they think they can get away with it," Bradshaw said.
The NECC is owned by businessman Greg Conigliaro and his brother-in-law Barry Cadden, a pharmacist. Together with extended family, Conigliaro operates twelve companies. Four of them, including a company that recycles foam insulation, are run from the same complex as the NECC.
CBS News asked to the NECC for comment. They responded with an email, saying that while they continue to cooperate with federal and state authorities, they specific allegations made by the former employees.
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