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FDA searches pharmacy amid outbreak investigation

Agency won’t say if criminal inquiry is taking place

FDA agents worked into the evening Tuesday at the offices of the NewEngland Compounding Center.

BARRY CHIN/GLOBE STAFF

FDA agents worked into the evening Tuesday at the offices of the NewEngland Compounding Center.

FRAMINGHAM — The investigation of the Framingham compounding pharmacy at the center of a nationwide fungal meningitis outbreak has ­expanded to include criminal investigators.

Agents from the Food and Drug Administration were at the offices of New England Compounding Center Tuesday and worked into the evening. They wore blue jackets bearing the yellow letters “FDA OCI,” for the FDA Office of Criminal Investigations, as they went in and out of the brick office building on Waverly Street.

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A number of unmarked government cars were parked in the area.

Steven Immergut, an FDA spokesman, said the agents were there as part of the agency’s ongoing investigation into the outbreak, which is believed to be caused by contaminated steroids made by the compounding pharmacy. He would not comment on whether the agency is conducting a criminal inves­tigation.

US Attorney Carmen M. Ortiz issued a statement Tuesday acknowledging her office’s involvement in the inquiry.

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“I can confirm that this office and our law enforcement partners are investigating allegations concerning the New England Compounding Center,” she said in the statement. “I think that it is entirely premature to suggest what the results of the investigation will be.”

Brad Bailey, a prominent Boston criminal defense attorney and a former prosecutor, said in an interview Tuesday night that investigators would have needed probable cause to secure a warrant to search the facility, and that such an effort would be based on a criminal inquiry.

“It means that a clerk magistrate has to determine that either there is evidence of a crime, or fruits of a crime or contraband, located at the laboratory, and there’s sufficient basis to issue a warrant,” he said. But he said the search does not mean that a crime has occurred.

The compounding pharmacy’s lawyer issued a statement Tuesday night saying, “It is difficult to understand the purpose of this search, since we have been clear that New England Compounding Center would provide, and has provided, anything requested. We’ve been clear that warrants weren’t needed.”

Health officials say they have traced the outbreak to a possibly contaminated injectable steroid. On Monday, the FDA said two other New England Compounding products, ­another steroid and a medication used in heart surgery, may also be involved in the outbreak.

Fifteen people have died, and 233 cases have been reported in 15 states, the US Centers for Disease Control and Prevention have said.

Kay Lazar and Milton Valencia of the Globe staff contributed to this report. Liz Kowalczyk can be reached at kowalczyk@
globe.com.
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