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Among the issues cited was NECC’s manipulation of a sterile injectable product that led the FDA to be “especially concerned about potential microbial contamination.”

The committee said NECC’s actions “call into question whether the NECC was operating as a traditional compounding pharmacy or on a commercial scale as a drug manufacturer.”

Compounding pharmacies, regulated primarily by states, specialize in customizing doses for patients who have allergies to ingredients in FDA-approved drugs or who might need smaller dosages than what’s available commercially. But some pharmacies have pushed into full-scale manufacturing.

Committee members say they want to know “how long NECC has been operating in this manner and why, six years after the FDA’s warning letter and 10 years after an inspection relating to methylprednisolone acetate produced and distributed by the NECC, the company was able to continue to do so.”

In its letter, the committee also said Cadden had declined to speak to it, although he was not invoking his rights under the Fifth Amendment. Criminal investigators have raided the company, but no one has been charged with a crime.

NECC spokesman Andrew Paven said he hadn’t seen the committee’s letter but the company continues to cooperate with the ongoing investigation.

NECC worked cooperatively with the Massachusetts Board of Registration in Pharmacy to resolve to the Board’s satisfaction any issues brought to the company’s attention,” he said by email.

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Associated Press writers Steve LeBlanc and Jay Lindsay contributed to this report.