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T04-03 |
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At the request of the Food and Drug Administration (FDA), the U.S. District Court for the Northern District of Ohio issued a seizure warrant on February 3, 2004, for seizure of various neonatal chemistry and isoelectric focusing diagnostic kits at PerkinElmer Life Sciences, Inc., (PerkinElmer) in Norton, Ohio. The test kits are used to screen for several genetic diseases in newborns and hemoglobin and central nervous system diseases in adults, such as sickle cell anemia and multiple sclerosis. The U.S. Marshals Service executed the seizure warrant on February 4, 2004.
PerkinElmer's devices are adulterated under the federal Food, Drug, and Cosmetic Act because they were not manufactured in accordance with FDA's good manufacturing practice quality system regulation.
FDA inspections of PerkinElmer revealed that the firm has continually failed to follow the requirements of the quality system regulation when manufacturing in-vitro diagnostic kits. FDA sent PerkinElmer a letter citing these unacceptable practices, giving the company an opportunity to correct the violations, but the company failed to take appropriate corrective actions.
These violations do not necessarily mean that PerkinElmer's diagnostic products will harm patients, but the firm's failure to follow the quality system regulation decreases the level of assurance that the devices are safe and effective.
The FDA has initiated this action as part of its responsibility to promote and protect the public health by enforcing the Food, Drug, and Cosmetic Act. FDA's mission includes ensuring the safety or safety and effectiveness of a broad spectrum of regulated products, including food, human and animal drugs, vaccines, blood products, medical devices, devices that emit radiation, and cosmetics.
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