NEW YORK, Feb. 5 (GenomeWeb News) - The US Food and Drug Administration announced yesterday that it had legally seized PerkinElmer Life Sciences' neonatal chemistry and isoelectric focusing diagnostic kits because the kits were "adulterated under the federal Food, Drug, and Cosmetic Act."
In the statement, the FDA said that the US District Court for the Northern District of Ohio had given it a warrant to seize the kits in PerkinElmer's Norton, Ohio, facility, and that the US Marshal's service had executed the warrant Feb. 4.
The FDA said the kits, which are used to screen for genetic diseases such as sickle cell anemia and multiple sclerosis, "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," the agency statement said. "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."
Last night, PerkinElmer responded to these actions, saying in a statement that it " believes the products affected by today's FDA action are safe."
The company also said it had been working with the FDA on the issue of GMP at the Norton, Ohio, facility and that it "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."
In the meantime, the company said it would help its customers find other sources of IVD supplies.
Sales of these products, the company said, were under $10 million in 2003. This action, it said, "is not expected to have a material financial impact." Also, the company said that it would be transferring the products made in the Norton, Ohio, facility to another location, as part of a planned facility rationalization.
As of midday, the company's stock had dropped $.16.