FDA Details Contamination at Pharmacy
The FDA has made public their findings within the New England Compounding Center (NECC), the pharmacy that is responsible for the meningitis outbreak that has made over 400 people sick and killed over 30. It is believed that thousands of people have been exposed to the fungus that caused fungal meningitis.
Rather than producing the tailor-made drugs for patients that the facility was allowed to produce, they became a major drug maker that supplied some of the most well-known hospitals in the country with medications. Some of the hospitals they supplied included Yale, Harvard, and the Mayo Clinic. They did this with very little oversight by federal regulators.
One area that officials were concerned with was how close the company is to a recycling plant. At this plant, there were many freight trucks, excavators, plastics, old mattresses, and other materials that caused a lot of dust to be released into the air. One of the owners of this recycling plant also owns the pharmacy and is known for not always complying with regulations and being the subject of complaints.
According to the inspection report, it is believed that the company’s practices led to the fungus contaminating the vials of methylprednisolone acetate, which is a pain medication that is administered through an epidural injection in the spine.
The inspectors noted that 83 of 321 of the vials that were examined in one lot contained the fungus that has been linked to the meningitis outbreak. They could visibly see that there was foreign matter in the vials that were greenish black in color. Another 17 of the vials had a white material within them.
The report states that NECC had only tested one vial from that particular lot and it was that vial that showed the medication to be sterile. The FDA tested a total of 50 vials and found all of them had some sort of microbial growth within them.
One of the most concerning findings was that the company’s own testing in 2012 found that the clean rooms had been contaminated with mold or bacteria that exceeded limits established by the own company. The levels were so high that remedial measures that should have been taken were never taken. There were some cases where entire testing dishes were filled with some kind of overgrowth.
There was also an issue with NECC’s air-conditioning system. Employees said the system would be shut off between 8 p.m. and 5:30 a.m. in the rooms where sterile drugs were manufactured. In drug manufacturing, it is important that proper humidity and temperature are maintained to keep microbes from growing.
The company says it will review the FDA’s report and continue to cooperate with the investigation. They said they will provide the FDA with the appropriate comments after they have had enough time to evaluate the report.
The neighboring recycling center was not a major factor in the investigation, but it did become a small part of the inquiry so that investigators could find out more about the possible role it plays. The report notes that the rooftop air conditioning units on the pharmacy are only 100 feet away from some of the recycling plant’s activities. Neighbors have complained about smells, dust, and debris that come from the plant.
Many medical facilities have been shaken up about the happenings within the NECC. This is because the 3,000 customers of the pharmacy trusted them to manufacture sterile medications.