FDA Find Sterility Issues at Another Mass. Pharmacy
An inspection by federal regulators of Massachusetts-based Ameridose – a sister company to the specialty pharmacy linked to the deadly meningitis outbreak – uncovered several potential sources of contamination in the facility where the drug company manufactures injectable painkillers, blood thinners, and pregnancy medications.
The Associated Press (AP) reports that Food and Drug Administration (FDA) officials during their inspection of the Ameridose facility found leaky ceilings, insects near a supposedly sterile area, and cracks in the ceiling and walls of a clean room used to manufacture sterile drugs.
The sterility equipment at the facility was found to contain “thick residues that were orange, brown, and green” on them, according to AP. The officials reported that a bird was found flying in a room where drugs were stored. The FDA also said the company failed to investigate at least 53 incidents of bacterial contamination that occurred during testing of stock drug solution.
Ameridose shut down for inspection after its sister company, the New England Compounding Center (NECC), was linked to the fungal meningitis outbreak that has sickened more than 450 people and killed 32 from 19 states. Though none of Ameridose’s drugs have been found to cause any illness or infection, the company voluntarily recalled all of its products last month at the request of the FDA.
Ameridose said in a statement it will work with the FDA to address the issues found during the inspection. Both Ameridose and NECC were founded by Barry Cadden and Greg Conigliaro but claim to be separate enterprises with different management teams, according to AP.