Ameridose – the sister firm of the pharmaceutical company at the center of the fatal fungal meningitis outbreak that has been sweeping the country – was recently inspected by federal officials, who found many serious flaws in its drug-making procedures. A leaking ceiling in the “clean room” and a bird fluttering about a room where sterile drugs are supposed to be packed were the tip of the iceberg.
The FDA was so alarmed by conditions at the Ameridose facility that they urged the company to recall every single one of its products, since there was no guarantee any of them were sterile. Cracked and peeling walls, insects, gaps under clean-room doors, bacteria and fungus in packaged products, and more problems astonished inspectors.
Additionally, Ameridose officials failed to look into three instances when their drugs failed sterility tests this year, and they ignored 45 different cases in which mold and bacteria were isolated from critical areas – such as the fingers of employees who were preparing drugs. When microbes were detected, Ameridose officials failed to subculture them to determine what they were, despite identifying multiple units that were contaminated.
If you have suffered illness or injury, or if your loved one has died because of adverse effects from an Ameridose product, please contact The Cochran Firm DC today to schedule a free case evaluation with an experienced product liability lawyer.
