Compounding center aware of facility contamination for months, FDA reports

Patient Safety Monitor Insider

October 31, 2012

The Food and Drug Administration (FDA) released a report of inspections conducted at the New England Compounding Center, the Massachusetts pharmacy connected to the national meningitis outbreak. The Compounding Center knew about bacterial and fungal contamination within its rooms for nearly nine months but did not take corrective action, according to the FDA.  More than 300 people in 18 states have experienced infections related to tainted drugs from the company, and 25 people have died from drug-related complications.

According to the FDA’s report, of the 321 vials of the steroid methylprednisolone acetate, the drug causing many of the fungal infections, 83 contained a “greenish-black foreign matter” visible to the naked eye, while 17 vials contained “white filamentous material.” All 50 of the vials that the FDA analyzed contained viable microbial growth. The Compounding Center is under criminal investigation, so to avoid compromising the investigation, FDA officials did not elaborate on the implications of their findings.

Source: NPR