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By Mike Baker
Associated Press
POSTED: 07:54 p.m. EDT, Mar 20, 2009
RALEIGH, N.C.: Several months before federal investigators linked a North Carolina syringe manufacturer to hundreds of illnesses and five deaths, a whistleblower wrote to regulators to warn about the poor conditions inside a room vital to producing a sterile product.
U.S. Food and Drug Administration records released Friday to the Associated Press through a Freedom of Information Act request show no sign that inspectors tried to address the concerns of the AM2PAT Inc. employee. She told the agency in a June 2007 e-mail, months before the outbreak was discovered, the firm was not operating appropriate temperatures in its cleanroom — an environmentally controlled site where air is constantly monitored.
Federal investigators believe a rush to maximize profits led the company to produce heparin and saline syringes that sickened hundreds, resulting in spinal meningitis and permanent brain damage for some.
The whistleblower, whose name is redacted, also said management ignored complaints and did not allow employees to talk to FDA officials during an inspection.
The FDA's response to the whistleblower appeared delayed and disjointed. An inspector tried to visit AM2PAT a week after the agency received the e-mail, but was responding to a separate complaint in which a patient's husband found ''black and brown floating matter'' in an unopened syringe. The company made syringes used to flush IV lines.
But instead of visiting AM2PAT's new facility in Angier, about 20 miles south of Raleigh, the inspector went to the company's old location and found nobody there.
Another month passed before the inspector visited the company's new location. An inspection report from that visit doesn't give any indication the official investigated the cleanroom's temperature or spoke with any employees.
Instead, the inspector walked through the site with the company's quality control director, Ravi Sharma, and later the company's president, Dushyant Patel, who flew to North Carolina from Chicago to attend part of the inspection.
The FDA's report said the inspector found only a labeling problem, concluding the company had not been putting its name or address on labels for nearly two years. Patel said in response they should not be punished because the FDA should have caught the omission.
The FDA did not respond to requests Friday to answer questions about the inspection or the whistleblower report.
Sharma and another plant manager, Aniruddha Patel, were each sentenced last month in federal court to 41/2 years in prison for fraud and allowing tainted drugs into the marketplace. Prosecutors are still searching for Dushyant Patel, who faces 10 charges including fraud; investigators believe he has fled to his native India.
The findings from the August 2007 inspection were tame compared to what inspectors reported when they returned a few months later, after the Centers for Disease Control reported an outbreak of illness connected to AM2PAT syringes. In December 2007, inspectors found numerous problems, including poor documentation, untrained workers and other violations so extensive that it ''made it impossible for the company to maintain sterility in the product,'' the FDA has said.
Paperwork at the plant during that inspection appeared to corroborate the whistleblower's concerns, according to the inspection. It said the plant's air conditioning unit did not have sufficient capacity to control temperatures. But instead of ceasing production, the company raised the temperature limit of its alert system used to warn of excessive heat.
Prosecutors have said that the company's microbiologist was a teenager who had dropped out of high school. Photographs introduced as evidence last month show a cleanroom with a window fan patched with duct tape. Others show paint chipping off the facility's floor, once home to motorcycle manufacturing.
RALEIGH, N.C.: Several months before federal investigators linked a North Carolina syringe manufacturer to hundreds of illnesses and five deaths, a whistleblower wrote to regulators to warn about the poor conditions inside a room vital to producing a sterile product.
U.S. Food and Drug Administration records released Friday to the Associated Press through a Freedom of Information Act request show no sign that inspectors tried to address the concerns of the AM2PAT Inc. employee. She told the agency in a June 2007 e-mail, months before the outbreak was discovered, the firm was not operating appropriate temperatures in its cleanroom — an environmentally controlled site where air is constantly monitored.
Federal investigators believe a rush to maximize profits led the company to produce heparin and saline syringes that sickened hundreds, resulting in spinal meningitis and permanent brain damage for some.
The whistleblower, whose name is redacted, also said management ignored complaints and did not allow employees to talk to FDA officials during an inspection.
The FDA's response to the whistleblower appeared delayed and disjointed. An inspector tried to visit AM2PAT a week after the agency received the e-mail, but was responding to a separate complaint in which a patient's husband found ''black and brown floating matter'' in an unopened syringe. The company made syringes used to flush IV lines.
But instead of visiting AM2PAT's new facility in Angier, about 20 miles south of Raleigh, the inspector went to the company's old location and found nobody there.
Another month passed before the inspector visited the company's new location. An inspection report from that visit doesn't give any indication the official investigated the cleanroom's temperature or spoke with any employees.
Instead, the inspector walked through the site with the company's quality control director, Ravi Sharma, and later the company's president, Dushyant Patel, who flew to North Carolina from Chicago to attend part of the inspection.
The FDA's report said the inspector found only a labeling problem, concluding the company had not been putting its name or address on labels for nearly two years. Patel said in response they should not be punished because the FDA should have caught the omission.
The FDA did not respond to requests Friday to answer questions about the inspection or the whistleblower report.
Sharma and another plant manager, Aniruddha Patel, were each sentenced last month in federal court to 41/2 years in prison for fraud and allowing tainted drugs into the marketplace. Prosecutors are still searching for Dushyant Patel, who faces 10 charges including fraud; investigators believe he has fled to his native India.
The findings from the August 2007 inspection were tame compared to what inspectors reported when they returned a few months later, after the Centers for Disease Control reported an outbreak of illness connected to AM2PAT syringes. In December 2007, inspectors found numerous problems, including poor documentation, untrained workers and other violations so extensive that it ''made it impossible for the company to maintain sterility in the product,'' the FDA has said.
Paperwork at the plant during that inspection appeared to corroborate the whistleblower's concerns, according to the inspection. It said the plant's air conditioning unit did not have sufficient capacity to control temperatures. But instead of ceasing production, the company raised the temperature limit of its alert system used to warn of excessive heat.
Prosecutors have said that the company's microbiologist was a teenager who had dropped out of high school. Photographs introduced as evidence last month show a cleanroom with a window fan patched with duct tape. Others show paint chipping off the facility's floor, once home to motorcycle manufacturing.
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