1-year probation contingent on an independent evaluator's assessment
of its compliance.
As NECC and the board bantered back and forth, an FDA inspector
showed up at NECC, along with 2 representatives from the state phar-
macy board, prompted by a complaint from a competing manufactur-
er about a substance called Trypan Blue, a dye used in cataract and
heart procedures.
The inspectors confirmed that NECC did have a new set of written
procedures for compounding. However, when the FDA inspector
asked Mr. Cadden questions about compounding Trypan Blue, he
"became indignant" and said he didn't have time to answer questions.
When asked whether he had Trypan Blue in stock, Mr. Cadden said
no. The investigators then discovered 189 vials of the substance in a
drawer in the clean room.
In all, the Massachusetts board investigated 8 complaints against
NECC between 1999 and 2004 for unprofessional conduct, unethical
conduct and failure to adhere to the standards of practice. Never did
the board deliver more than a slap on the wrist. The agency did not
return phone calls for this story.
In a 2006 report, the independent evaluator the board hired wrote
that NECC had made "significant improvements" but still had a long
way to go to be in compliance with USP standards. The firm needed
better documentation, needed to actually follow procedure, needed to
do adequate sterility testing and needed to do a total redesign of
Clean Room 1 (floor, ceiling, HVAC). Mr. Cadden agreed to replace the
HVAC, but suggested the other improvements weren't needed.
Apparently that was enough for the state pharmacy board. It agreed
that he had satisfied the terms of the consent agreement.
Meanwhile, the FDA continued its pursuit. A 2004 inspection
revealed that NECC was manufacturing drugs in volume, without indi-
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