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Owner of Meningitis-Linked Pharmacy Declines to Testify Before Congress
Date:11/14/2012

heir injection.

On Thursday, Hamburg is scheduled to testify before the Senate Committee on Health, Education, Labor, and Pensions.

Last month, FDA investigators who toured the Framingham plant found foreign, "greenish-black" material in some vials of the injectable steroid suspected as the cause of the illnesses, federal health officials said. The contaminated product was one of a host of potential violations discovered during the recent inspection, the officials said.

"The investigators observed approximately 100 vials of the steroid drug, which purports to be a sterile injectable drug, that had a greenish-black foreign material and a white filamentous [containing filaments] material inside," Steven Lynn, director of the FDA's Office of Manufacturing and Product Quality, said during an Oct. 26 news conference.

In addition, the company couldn't prove that the equipment used to sterilize these products was actually able to sterilize them, Lynn said.

The FDA also found that the company wasn't able to keep its "clean room" clean, Lynn said. "A clean room is a space designed to maintain a controlled environment with low levels of airborne particles and surface contamination," he explained.

The U.S. Centers for Disease Control and Prevention on Friday had the following state-by-state breakdown of cases: Florida: 23 cases, including 3 deaths; Georgia, 1 case; Idaho, 1 case; Illinois, 2 cases; Indiana: 52 cases, including 4 deaths; Maryland: 23 cases, including 1 death; Michigan: 128 cases, including 7 deaths; Minnesota: 11 cases; New Hampshire: 13 cases; New Jersey: 27 cases; New York: 1 case; North Carolina: 3 cases, including 1 death; Ohio: 16 cases; Pennsylvania: 1 case; Rhode Island: 3 cases; South Carolina: 1 case; Tennessee: 81 cases, including 13 deaths; Texas: 2 cases; Virginia: 50 cases, including 2 deaths.

Ten of the 438 cases involve what the CDC calls "peripheral joint infection," meaning an infection in a knee, hip
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