Conditions at Ameridose, a Massachusetts-based pharmaceutical drug supplier that shares some of the same owners as the company tied to the deadly nationwide outbreak of fungal meningitis, are such that it can not guarantee the safety of any of the products exiting its headquarters.
According to The New York Times, the Food and Drug Administration released a 20-page report this week following an agency inspection of Ameridose facilities that are used to prepare and store drugs as well as the company’s record-keeping procedures. Last month, Ameridose issued a recall on all recent shipments of drug products from its facility in Massachusetts citing safety concerns.
Ameridose is connected through several owners with New England Compounding Center. That company is responsible for the ongoing outbreak of fungal meningitis that has claimed 32 lives and sickened nearly 440 more people with a life-threatening infection. NECC produced contaminated vials of an epidural steroid injection that was tainted with a fungus, methylprednisolone acetate.
This injectable drug was sent to more than 70 pain centers and other health care facilities earlier this year. As many as 14,000 vials were sent and thousands of people were at risk of developing that potentially fatal form of fungal meningitis.
Based on the reports issued by the FDA this week, NECC and Ameridose shared more than owners but the same penchant for keeping unsanitary conditions at its drug processing facilities, too. These environments are supposed to be free of any and all potential toxins but based on the inspection report, conditions were anything but sanitary.
Samples of drug solutions collected by the FDA inspectors were contaminated with various forms of germs. Solutions were kept or mixed in rusted and otherwise unsanitary equipment. In areas that were to be kept sterile, insects crawled and a bird was even observed flying inside.
The Times also reports the FDA found Ameridose to be severely lacking in its record-keeping duties, including reacting to reports of problems linked to the use of drugs prepared at its facilities. The FDA described it as failing to “adequately investigate” complaints about its drugs but many of the problems could have resulted in more widespread problems, similar to those being experienced at NECC.
The FDA report notes that complaints of “fetal distress, a hyperstimulated uterus and maternal hemorrhaging from a drug used in labor, and oversedation and breathing trouble from fentanyl, a powerful narcotic,” were not investigated by the company.
There have been no reports of illnesses linked to any Ameridose drugs since it has issued the wide-ranging recall, according to the report.