An FDA inspection of the New England Compounding Center (NECC) linked to the meningitis outbreak revealed the company may have known about contamination for months before the outbreak but did not take action. The inspection’s results revealed numerous conditions that justify the recall of all NECC products issued earlier this month. Inspectors found visible growth of microorganism films (also called “sheets”) in supposedly clean rooms, water pooling around a leaky boiler, and discoloration of equipment used to sterilize compounds. They also found that the company knew about contamination for months but failed to act.
The outbreak tied to the NECC has resulted in more than 300 infections, mostly fungal meningitis, and caused 25 deaths in 18 states. Most of the infections are tied to steroid injections used for back pain, but other medications from NECC have been found to be contaminated. The batch of steroid injections at the center of the investigation were used on or after September 26, 2012, but quality concerns about NECC began long before the current outbreak.
By USARECALLS
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