Product category:
Clinical chemistry analysis
News Release from: Perkin Elmer LAS (UK)
Edited by the Laboratorytalk Editorial
Team on 09 February 2004
PerkinElmer responds to FDA action
US Marshalls seize 'adulterated' Wallac diagnostic kits from PerkinElmer plant for failure to comply with good manufacturing practice regulations
PerkinElmer has issued the following statement in connection with the seizure by US FDA officials of various neonatal chemistry and isoelectric focusing diagnostic kits, sold under the Wallac brand name, from the PerkinElmer facility at Norton, Ohio PerkinElmer said that it had been working for some time with the Food and Drug Administration (FDA) regarding good manufacturing practices at its Norton, Ohio facility and that it believes the products affected by the FDA action on 4 February 2004 are safe
This article was originally published on Laboratorytalk on 19 Apr 2002 at 8.00am (UK)
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PerkinElmer believes it has made significant progress in addressing FDA concerns and intends to continue to work with the FDA to ensure that its manufacturing practices for regulated products are fully compliant with FDA regulations.
PerkinElmer intends to help its customers find alternative sources of supply until it can resume shipment of its products.
The company also noted that 2003 sales of the affected products were less than $10 million.
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The company said the action is not expected to have a material financial impact.
Additionally, the company added that as part of its previously announced facility rationalisation, it has been in the process for approximately a year of transferring the manufacture of the products made in the Norton site to another location.
The US Food and Drug Administration issued this statement: Adulterated medical devices seized.
At the request of the Food and Drug Administration (FDA), the US District Court for the Northern District of Ohio issued a seizure warrant on 3 February 2004, for seizure of various neonatal chemistry and isoelectric focusing diagnostic kits at PerkinElmer Life Sciences in Norton, Ohio.
The test kits are used to screen for several genetic diseases in newborns and haemoglobin and central nervous system diseases in adults, such as sickle cell anaemia and multiple sclerosis.
The US Marshals Service executed the seizure warrant on 4 February 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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