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.
If you experience symptoms of meningitis such as fever, headache, stiffness in the neck, dizziness, and nausea after a steroid injection, you should seek medical attention.
Outbreak May Be Due to Procedural Failures
According to the FDA’s inspection released on Friday, the company’s own tests showed unacceptable levels of bacterial growth in clean rooms used for the preparation of sterile injections. In January, growth had reached “action levels,” the point at which the company was supposed to take further action, but there is no indication that NECC did anything to control microorganism growth. NECC personnel did not even identify what microorganisms were found.
In addition to its failure to address action levels of bacteria, the FDA noted other procedural problems at NECC. The firm supposedly used sterile ingredients in its formulations, but the Pharmacy Director said they use non-sterile ingredients which were then sterilized, but the Director provided no evidence that sterilization was effective. Sterilization equipment used, including those used in the final step of sterilization, was found to be tarnished and discolored.
Staff at the NECC facility noted that air conditioning in clean rooms was turned off from 8pm to 5:30am. This cost-saving measure would allow conditions in the clean rooms to become warmer and more humid, encouraging bacterial growth.
Visible Contamination in Vials Tied to Meningitis
The FDA inspection report also noted that vials of injectable steroids and other compounds contained visible contaminants. Some had a greenish-black substance while others had a white, stringy material. In addition, the FDA inspection showed living microbes in all 50 vials of steroid injection tested, and one examined microscopically seemed to be fungal.
General cleanliness was found to be a problem at NECC. A boiler outside of a preparation room was found to be leaking water into puddles that were contaminated with black granular material and thick white debris. Air conditioning vents were found to be covered with white material that visually resembled that found in some of the vials.
Too Many Sales, Too Little Regulation?
Concerns about NECC products have been piling up for years. At one point, a returned product that was thought to be associated with an adverse event troubled sales representatives at the company. According to a Reuters report, one NECC sales representative said of the incident, “I remember thinking, are we just selling too much? Were we growing sales faster than our lab could handle?”
NECC aggressively sought sales, sometimes illegally. Since its founding in 1998, the company has repeatedly been cited for using inappropriate forms for acquiring sales. It provided inappropriate prescription blanks to local physicians, then sought sales out of state when it had not been legally cleared to do so. In both cases, regulators only issued an informal reprimand.
The FDA warned NECC of violations in 2006, but said it was unable to take aggressive action because of a lack of clear regulatory authority over compounding facilities.
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