The Food and Drug Administration has uncovered several contamination issues at Ameridose, a drug-making facility that has the same founders as the New England Compounding Company — the compounding pharmacy linked to a deadly fungal meningitis outbreak.
The FDA released the results of a month-long inspection of the Westborough, Massachusetts company that makes injectable drugs, reports Yahoo! News.
The agency’s report, which was released on Monday and posted online, lists a mass of potential problems at the plant from manufacturing to sterility and quality control.
Through the course of their investigation into Ameridose, inspectors found insects within 10 feet of an area that was supposed to be sterile and where drugs are manufactured. They also found a bird flying into a room when drugs are sorted.
The report also cites leaks and cracks in the ceiling and walls of a clean room that is used to manufacture sterile drugs. The same room also contained “thick residues that were orange, brown, and green” on equipment meant for sterilization.
USA Today notes that, while no illnesses have been reported from the problems between 2008 and now, the conditions at the facility were less than acceptable. Sarah Lynn-Clark, a spokeswoman for the Food and Drug Administration, stated:
“[The firm] fails to test finished product for potency, failed to investigate complaints for ineffective products, failed to investigate violations of their own environmental sampling plan and fails to adequately maintain equipment and facilities used to manufacture sterile drug products.”
Krista Robinson, a spokeswoman for Ameridose, stated that the company is preparing a response to the FDA’s report. She stated that the company has “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.”
Robinson added that “Ameridose is committed to addressing all observations in order to enhance our existing systems.” Despite the lack of contaminated products that left the facility, the company has failed to report instances of ineffective medicine or problems with their drugs, according to the FDA report.
The company received 33 complaints claiming “lack of effectiveness” and “ineffectiveness” for its drugs, including those to treat acute asthma attacks and for pain relief. Doctors had also contacted the firm to say there were problems with the drugs, but the complaints were not classified as adverse events.
Incidents included were women who were given the company’s oxytocin to bring on labor, which caused fetal distress, severe post-birth bleeding, and shortness of breath. Heparin, a blood thinner, caused a patient to have a life-threatening adverse event. The firm’s pain medication fentanyl was given to cancer patients as an anasthetic and two patients went into respiratory distress from it.
It is not yet clear what effects the FDA report will have on the future of Ameridose.