Although NECC often cooperated with authorities, it was surprisingly defiant at times, too.
In an inspection in late 2004 involving questions about NECC’s production of a dye called Trypan blue, state and FDA inspectors attempted to interview Gregory Conigliaro, who co-owns the company. According to the FDA report, Conigliaro “became indignant [and] he said that he does not really have time to sit with us [and] answer all those questions.” Cadden then told his partner: “Don’t answer any more questions!”
In the same investigation, an FDA inspector asked Cadden whether he had any Trypan blue in stock. Cadden reportedly said “no, because he just compounds the drug if he receives the prescriptions for certain patients.” In the clean room, however, the inspector saw a drawer labeled “Trypan Blue” and asked Cadden to open it. It contained 189 vials of the dye.
The FDA ultimately deferred to the state pharmacy board to make Cadden clean up his operation. That’s because, despite evidence of small-scale mass production at the Framingham plant, FDA concluded that NECC was a compounder, not a drug manufacturer, and, therefore, fell under state regulations.
In a separate development, FDA inspectors found more than a dozen sterility problems at Ameridose, a sister drugmaking facility of which Cadden is also a co-owner.
According to a report released Monday, inspectors found that Ameridose repeatedly failed to perform adequate sterility tests, to investigate more than 53 instances of microbiological contamination in pain medications, and to clean bacteria and mold found in its equipment. A company spokesman said Ameridose has not had “any instance of contaminated products” over the past six years and was preparing a full response to the FDA’s report.
Both NECC and Ameridose have closed in. Cadden’s attorney, Bruce Singal, did not respond to a telephone call and e-mail request for comment.
Lena H. Sun contributed to this report.