Regulatory Focus™ > News Articles > FDA Raids Compounding Facility Linked to Meningitis Outbreak

FDA Raids Compounding Facility Linked to Meningitis Outbreak

Posted 17 October 2012 | By Alexander Gaffney, RAC

Criminal investigators from the US Food and Drug Administration (FDA) have raided the New England Compounding Center (NECC), the facility linked with supplying tainted injectable steroid products that have infected hundreds with a dangerous form of fungal meningitis that has already claimed the lives of 19.

The move, made 17 October, is perhaps FDA's most forceful yet against the pharmacy. NECC has thus far been cooperating with the agency on an extensive but voluntary basis.

It is not immediately clear if any specific event precipitated the raid. The company's lawyer told reporters that NECC had been cooperating with FDA and was disappointed at the agency's decision to activate its law enforcement resources. "[A]sking would have produced the same result," Paul Cirel, a lawyer with Collora LLP, said in a statement. "It's difficult to understand the purpose of this search, since we have been clear that [NECC] would provide, and has provided, anything requested."

Some pressure may be attributable to congressional members, who have ratcheted up calls for a criminal investigation by the Department of Justice (DOJ) in recent days. 

But it also remains unclear why FDA waited until now to raid the facility. The outbreak of meningitis has been strongly linked to the facility since at least 1 October 2012, when FDA began to inspect the NECC plant and first found vials contaminated with the fungus. The 16 days between the time of the initial inspection and FDA's takeover of the facility could potentially become a source of tension for congressional investigators who have already called on FDA to explain its actions in the case.

Read more:

Reuters - Feds raid Massachusetts lab tied to meningitis outbreak

Wall Street Journal - Pharmacy in Outbreak Is Raided

The New York Times - Investigators Visit Company Tied to Meningitis Cases

Modern Healthcare - Investigators visit Mass. firm in meningitis case

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