FDA probe finds contamination issues at Ameridose
WASHINGTON — Federal health inspectors found numerous potential sources of contamination, including leaky ceilings and insects, at a drug-making facility that has the same founders as the specialty pharmacy linked to a deadly meningitis outbreak.
The Food and Drug Administration on Monday released the results of a monthlong inspection of Ameridose, a Westborough, Mass.-based company that makes injectable drugs. The agency’s report, posted online, lists a host of problems at the plant, ranging from manufacturing to sterility to quality control.
Inspectors said they found insects within 10 feet of a supposedly sterile area where drugs were manufactured. In another case, inspectors reported a bird flying into a room where drugs are stored.
Elsewhere, the report cites leaks and cracks in the ceiling and walls of a clean room used to manufacture sterile drugs. The same room contained “thick residues that were orange, brown, and green” on equipment used for sterilization.
FDA inspectors also said the company did not investigate at least 53 incidents of bacterial contamination that arose during testing of stock drug solution.
“There is no documented evidence that your firm implemented permanent corrective actions to prevent these sterility events from recurring,” investigators wrote.
Ameridose agreed to shut down for inspection in October after tainted steroids from its sister company, the New England Compounding Center, were linked to a fungal meningitis outbreak that has spread to 19 states and caused 32 deaths. Ameridose operates two facilities in Westborough and provides medication in prefilled oral syringes to hospitals nationwide. Its drugs range from painkillers to blood thinners to pregnancy drugs.
Late last month, the company agreed to recall all of its products under pressure from FDA regulators. FDA officials previously said they have not connected any Ameridose drugs to infection or illness, but they have concerns about the products’ sterility.
Inspectors visiting the company’s plant also questioned whether some of Ameridose’s drugs work properly. Inspectors said that the company received 33 complaints from patients and doctors claiming “lack of effect” with various drugs.
Regulators report that Ameridose also failed to investigate potentially serious side effects reported with drugs. One complaint involving the company’s painkiller fentanyl states the “patient was over-sedated, unresponsive.” A complaint for oxytocin, which is used to induce labor in pregnant women, states that the “patient had shortness of breath, the throat was closing, and coughing.”
Ameridose said in a statement Monday that it will work to address the issues cited by FDA. But it stressed that “Ameridose’s history shows clearly that we have not had any instance of contaminated products over the course of the past six years, which covers the manufacture and shipment of 70 million units of product.”
Ameridose and NECC were founded by brothers-in-law Barry Cadden and Greg Conigliaro. Ameridose says it is a separate entity with distinct management. Since the outbreak, Cadden, the lead pharmacist at NECC, resigned his post as director at Ameridose. He is scheduled to testify before Congress at a hearing Wednesday examining the outbreak.
Last week Ameridose laid off nearly all of its 650 employees and 140 employees at its marketing and support arm, Medical Sales Management, due to the company’s extended shutdown.