Saturday, March 21, 2009

Whistleblower Warned FDA About Syringe Plant

"Several months before federal investigators linked a North Carolina syringe manufacturer to hundreds of illnesses and five deaths, a whistle-blower wrote to regulators to warn about the poor conditions inside a room vital to producing a sterile product." FDA records released Friday "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." The unnamed whistleblower also said "management ignored complaints and did not allow employees to talk to FDA officials during an inspection." Sadly, the FDA's response was "delayed and disjointed." Read more.

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