The company at the center of the deadly fungal meningitis outbreak has been under increased oversight since a 2006 inspection of its pharmacy labs discovered widespread deficiencies in protocols for manufacturing drugs.
According to an AP report, New England Compounding Center was subject to a third-party inspection in 2006. That inspection revealed that the Framingham, Mass., company was lacking in safety protocols that could endanger the sterility of the drugs it was commissioned to produce. The inspection noted that the company failed to have any standard written procedures for manufacturing drugs, including the operation of equipment, and that sparse record-keeping was done by the company, overall.
When Massachusetts health officials visited the NECC labs earlier this year, an inspection report obtained by AP via a special request, found that the company had allegedly improved on these deficiencies. Still, NECC was able to ship more than 14,000 potentially contaminated vials of an epidural steroid injection that has already sickened more than 300 people and been blamed for at least 23 deaths after causing recipients to develop fungal meningitis.
Since the dawn of the outbreak and a Food and Drug Administration investigation which was able to determine that 50 sample vials of methylprednisolone acetate were contaminated with a fungus that was responsible for the deadly meningitis outbreak. Victims continue to be confirmed by health officials in at least a dozen states.
In already reported anomalies associated with this outbreak that point to questions about NECC, the company was reportedly only licensed to produce enough vials of methylprednisolone acetate that were confirmed by prescriptions already written. Considering the volume of vials recalled by the company earlier this month after they were linked to the outbreak of fungal meningitis, it’s become clear that NECC likely violated its license in producing so many vials of the drug without a prescription to confirm them.
More than 70 pain management centers and other health care facilities received the potentially contaminated vials from NECC and since the outbreak, concerns have grown that other drugs produced by NECC may also be contaminated and more than 100,000 people are being warned that they could be at risk of developing a similar fungal infection.
NECC has been subject to increased oversight since at least 2002 and federal health officials this week have demanded a wide array of documents from the company to determine how lapses at the company caused so many of its drug products to become contaminated. The 2006 inspection by an independent company, Pharmaceutical Systems Inc., found “significant gaps” in many procedures carried out at NECC’s Framingham lab.
Similar allegations have been leveled against NECC in 2003, 2002, and in 1998, as both state and federal safety officials have logged similar complaints against the company’s procedural flaws.