• NECC shipped batches from two lots of the drug in question – an injectable steroid used to relieve pain – before it had results in hand from sterility tests the company performed on product. When the results came back, they indicated no contamination. Still, several sealed vials that came back under the company's recall of the product had black particles floating in them. Investigators are now looking into the thoroughness of the company's tests.
In addition, investigators found that when the company sterilized the steroids, they didn't operate the sterilization equipment long enough to meet minimum standards. The report also notes that the company failed to test the sterilization hardware to make sure it worked properly.
• A boiler next to the pharmacy's clean room had standing water under the boiler, reaching nearby walls. Water is a prime habitat for microbes, including the fungus associated with the outbreak of meningitis pegged to the tainted drug. Investigators have taken samples to see what sort of microbes the water holds.
• Mats designed to collect soil, dust, and other contaminants from the workers' shoes before they enter the clean room were darkened with filth and debris, suggesting the mats weren't changed as frequently as standards require.
• Tabletop boxes known as powder hoods, designed to prevent powders used in formulating a sterile drug from contaminating a product, were not thoroughly cleaned – providing a potential source of contamination.
This is not the first time that NECC has been in trouble with regulators. The company has been the target of special inspections several times over the past 13 years.
"It is tragic that these conditions were allowed to exist," writes Eric Kastago, president and owner of ClinicalIQ, in an e-mail. "There were lots of missed opportunities."
ClinicalIQ is a New Jersey-based consulting firm that focuses on compliance with sterile-compounding standards.