Many infractions at drug supplier
- Article by: DENISE GRADY and SABRINA
- November 12, 2012 - 9:05 PM
A federal inspection has turned up a long list of unsanitary conditions and unsafe practices at Ameridose, a drug supplier with some of the same owners as the pharmacy whose tainted steroid caused a nationwide outbreak of fungal meningitis that has killed 32 people and sickened more than 400 others.
A 20-page report issued Monday by the Food and Drug Administration (FDA) described drug solutions contaminated with germs, rusted and unsanitary equipment, and insects and a bird flying around in areas where sterile products were packaged and stored.
Inspectors also said the company did not "adequately investigate" complaints of serious reactions in patients that may have indicated problems with drug potency -- reactions including fetal distress, a hyperstimulated uterus and maternal hemorrhaging from a drug used in labor, and oversedation and breathing trouble from fentanyl, a powerful narcotic. There were also complaints of low potency in a sedative used to relieve anxiety in children undergoing surgery.
"FDA inspectors observed conditions and practices at Ameridose which demonstrated that the firm could not consistently assure that their injectable products were sterile and safe for use by patients," Sarah Clark-Lynn, a spokeswoman for the agency, said in an email.
So far, Clark-Lynn said, no infections have been linked to Ameridose, but all its products have been recalled, and its operations have been suspended since early October at the request of state regulators.
Ameridose said in a statement that it had had no instances of product contamination in its six-year history, during which it had shipped "70 million units of product." However, problems with potency did result in at least one recall.
The inspection report dealt another blow to the family behind Ameridose and its sister company, the New England Compounding Center, which made the fungal-tainted steroid medication that caused the meningitis outbreak.
The report comes just two days before the House Committee on Energy and Commerce is to hold a hearing on the outbreak. Barry Cadden, the chief pharmacist at the New England center, was subpoenaed by the committee after he declined its initial request to testify. Federal officials have said Ameridose was investigated because of concerns that it had some of the same business practices as New England Compounding.
Ameridose was founded by the same people who owned the New England Compounding Center -- Cadden, who has since lost his license; Gregory Conigliaro, a businessman; and Conigliaro's sister-in-law, Carla Conigliaro. It is based in Westborough, Mass.
© 2013 Star Tribune