The compounding agency at the center of the meningitis outbreak that has so far killed 23 people and sickened almost 300, was found to have problems with contamination control back in 2006.  At that time, The Massachusetts Board of Registration in Pharmacy investigated the NECC and found that there was inadequate contamination control.  Also, they found that there were no written standard operating procedures for the equipment.  Other specifics of the investigation include:

  • Insufficient documentation detailed that proper sterilization procedures had been followed
  • Uncovered and unlabeled containers, which could result in sterilization problems
  • A large hole in the ceiling above a workbench, which could also result in sterilization problems
  • Grimy residue on the outside of several pieces of equipment

The pharmacy allegedly addressed these issues, and though they were supposed to be on probation for a year, the probation was stayed.  At the time, there were already complaints about the same steroid that resulted in the meningitis outbreak, but all issues relating to the steroid were resolved.

The company even got a warning letter from the FDA in December of 2006, after all of the above occurred, because of contamination concerns.

Time and time again we see the same results from the FDA, whether it is with warnings it sends out to pharmaceutical companies, or in this case warnings it has sent out to a compounding pharmacy.  Warning letters are a fine starting point, but when the issue was clearly brought to the FDA’s attention, why was no further action taken to ensure that the contamination did not result in a deadly meningitis outbreak?