In the wake of lax workplace standards at a Massachusetts-area compounding pharmacy where contaminated steroid shots led to a deadly meningitis outbreak — resulting in 32 deaths across 19 states so far — the Food and Drug Administration (FDA) has found evidence of gross workplace negligence at another drug-making facility owned by the same people as the outbreak-linked pharmacy.
Ameridose — a Westborough-based compounding company founded by brothers-in-law Barry Cadden and Greg Conigliaro that provides pre-filled compounded medication to hospitals across the country — recently opened its doors to federal regulators for a month-long inspection after the public health crisis spurred by its partner, the New England Compounding Center. The FDA found that Ameridose fell far short of safety, cleanliness, and accountability standards, potentially compromising patient safety around the United States:
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.
Although the FDA has not formally linked Ameridose to any illnesses, and the company asserts that none of its drugs have been outright contaminated, the compounding pharmacy has seen dozens of complaints from hospitals and patients that their medications have not worked as advertised. The FDA’s recent findings raise concerns that lax safety procedures in the largely unregulated compounding pharmacy industry could lead to more public health emergencies and patient deaths.
Earlier this month, Massachusetts approved tighter state regulations on its compounded drug industry, empowering state officials to track the production and distribution of compounded drugs in an effort to prevent the kinds of outbreaks caused by the Massachusetts compounder. Later that week, Rep. Ed Markey (D-MA) introduced federal legislation to grant the FDA similar oversight of the industry.