Ameridose faced previous safety questions
By Todd Wallack
October 10, 2012
Dr. Pinna says…
There are two companies involved in the Meningitis outbreak:
AMERIDOSE and New England Compounding Center.
Both are owned by two men:
“Gregory Conigliaro, a Southborough engineer and entrepreneur, and his brother-in-law Barry Cadden, a pharmacist”
Evidently the local Massachusetts authorities and the FDA could not control their activities, even though both
organizations knew they were dangerous.
Now that 14 people are dead and over a hundred maimed, who is going to pay? And in which way? Money or
It will be very interesting to see whether the FDA which has unlimited funds and personnel at its
control will allow the perpetrators to walk away.
Ameridose LLC, the Westborough pharmacy that agreed to suspend certain operations Wednesday because of its ties to the Framingham company at the center of the deadly outbreak of fungal meningitis, has faced questions about its own safety procedures before.
In 2008, a US Food and Drug Administration inspection found that Ameridose had significant problems with production records, procedures, and drug testing, according to Validation Times, an industry newsletter.
The newsletter, which obtained a copy of the inspection report under the Freedom of Information Act, reported in 2010 that an FDA inspector found Ameridose did not test all its drug lots and shipped some products before receiving the results of tests to determine whether they were sterile.
The federal agency also found Ameridose was not following “what was expected” in its sterilization and quality assurance procedures, the newsletter said, and did not record all pertinent information in production records. The FDA refused to release a copy of the inspection report to the Globe, citing its ongoing investigation of Ameridose.
Shortly after the inspection four years ago, Ameridose issued a recall of the injectable painkiller fentanyl because the doses were too potent. According to the FDA, 155 bags of the powerful drug were recalled from five states.
In June of this year, a major group-purchasing organization for hospitals also found serious problems during a visit to Ameridose, according to court documents.
The group, Novation LLC of Irving, Texas, reported Ameridose failed to keep sterile products separate from nonsterile items in its warehouse and lacked standard procedures to make sure products were fully tested before being sold.
In fact, Novation said Ameridose’s quality controls were so lax that the company failed the audit. Novation also told its members that the organization planned to sever a purchasing agreement with Ameridose by the end of this month because of its concerns.
Ameridose — which has hundred of employees and supplies thousands of hospitals across the country — responded in August by suing Novation in federal court for libel, slander, breach of contract, and other alleged wrongdoings.
“The audit report provided by Novation was grossly inadequate, improper, negligently prepared and . . . intentionally misleading,” Ameridose said in the complaint.
In court documents, the company argued Novation used the faulty audit to damage Ameridose’s reputation and give the organization an excuse to switch to a pharmacy that offered bigger rebates.
The companies settled the suit last month. Novation spokeswoman Angie Boliver said the settlement and audit report are confidential. But as part of the settlement, Novation and Ameridose issued a joint statement in which each company praised the other and agreed to continue working together.
But in light of the developments of the past week, Boliver said Wednesday, Novation is closely monitoring the situation.
Both Ameridose and the New England Compounding Center — the company believed to be the source of the meningitis outbreak — are owned by Gregory Conigliaro, a Southborough engineer and entrepreneur, and his brother-in-law Barry Cadden, a pharmacist who lives in Wrentham. Cadden — who oversaw pharmacy operations at New England Compounding — which has ceased operations, has temporarily agreed to stop practicing under an agreement with state regulators.
Until recently, Ameridose was located around the corner from New England Compounding in Framingham. It moved to Westborough over a year ago.
Despite the ties, Ameridose has tried to distance itself from New England Compounding since the meningitis outbreak that has killed at least 12 people and sickened many more nationwide. The company has repeatedly said the firms “have separate production facilities, separate processes, and operate at separate locations.”
Still, Ameridose said Wednesday it agreed to voluntarily suspend operations until Oct. 22 “out of an abundance of caution, to ensure the safety of all Ameridose products.”
Ameridose and Massachusetts Department of Public Health officials said there is no indication that any Ameridose products were contaminated or unsafe.
But the health department said Ameridose’s temporary shutdown should enable state and federal regulators to inspect the company’s facilities while safeguarding the public. It said the FDA and state officials plan to conduct a “comprehensive investigation” of New England Compounding and Ameridose, including their ownership and governance structures. The FDA confirmed Wednesday it is investigating Ameridose, but declined to comment further