By DENISE GRADY and SABRINA TAVERNISE
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 on Monday by the Food and Drug Administrationdescribed 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 failed to “adequately investigate” complaints of serious reactions in patients that might 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 sedativeused to relieve anxiety in children undergoing surgery.
“F.D.A. 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 e-mail.
So far, Ms. 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, who say they need more time to investigate.
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 company said it was “committed to addressing all observations in order to enhance our existing systems.”
Eric S. Kastango, the president of Clinical IQ, a consulting firm that advises compounding pharmacies, said the F.D.A. findings at Ameridose were “just stupefying.”
“It’s an operation that is totally out of control,” he said. “Especially when you look at the patient complaints, that is scary as all get-out.”
Ameridose has been a major supplier of sterile injectable medications to hospitals and sells more than 2,200 blended drug products, including tranquilizers, anesthetics andantibiotics, according to its Web site.
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 scheduled 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, founded in 2006, is a private company and is not required to report its financial status publicly. Weeks of no activity seem to have taken their toll on the company, which has laid off or furloughed most of its 650 employees, as well as 140 employees of its sales affiliate, Medical Sales Management.
Ameridose was founded by the same people who owned the New England Compounding Center — Mr. Cadden, who has since lost his license; Gregory Conigliaro, a businessman; and Mr. Conigliaro’s sister-in-law, Carla Conigliaro. It is based in Westborough, Mass.
Robert C. Coleman, a retired F.D.A. investigator, said in an e-mail that while the inspection report was not the worst he had seen, “I would not want to use any of the company’s products.”
Mr. Kastango said part of the problem was that Ameridose, while run by pharmacists, had become a major drug manufacturer, without the proper procedures for safe mass production.
“It’s just unfathomable that they were able to operate for as long as they did,” he said, adding that he doubted Ameridose would ever be able to open for business again.
Andrew Pollack contributed reporting.
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