Friday, February 27, 2009

FDA Had Warned Syringe Lab of Violations

The AP reports that "Federal regulators warned a syringe manufacturer of 'several significant violations' in its quality control system two years before its needles triggered an outbreak of bacterial infections that prosecutors say led to at least five deaths and hundreds of illnesses," according to a letter released by the FDA Thursday. The agency "cited AM2PAT Inc. in August 2005 for nine serious violations at its factory in Raleigh." The letter indicated that "failure to establish and maintain procedures to control the environment 'could reasonably be expected to have an adverse effect on product quality.'" The company "vowed in 2005 to correct its deficiencies...and the FDA said a follow-up inspection in January 2006 was satisfactory." But, court documents show that "the next inspection didn't take place until December 2007" and that the agency "also conducted an inspection in August 2007...and found only a labeling problem."

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