BOSTON (Reuters) - A cracked vial here, a missing label there. The complaints coming into New England Compounding Center, the firm at the heart of the deadly U.S. meningitis outbreak, were piling up.
In March, regulators responded to a complaint from the prestigious Massachusetts Eye and Ear Infirmary about a potency concern involving one of the eye medications it purchased from NECC. The investigation is ongoing.
Over the summer, physicians at Ruby Memorial Hospital in West Virginia returned a bag of cardioplegia solution used in heart surgery after a patient did not respond as expected.
Testing showed the drug was not responsible, according to the hospital's pharmacy director, but the episode made at least one NECC sales representative uneasy.
"I remember thinking, are we just selling too much?" he said. "Were we growing sales faster than our lab could handle?"It is a question federal and state regulators are now examining. More than 300 people who received a tainted steroid sold by NECC that was used to treat back pain have been infected with fungal meningitis and 25 have died.
Interviews with former NECC employees and its customers, and a review of internal documents and newly-released state records, paint a picture of a company whose rapid growth was marred almost since its inception by breaches of regulations governing compounding practices. They also show how regulators failed to punish the company despite repeated violations of the rules.
27/10/2012 : By Toni Clarke and Sharon Begley / Yahoo News.
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