NEW YORK, Feb. 16 (GenomeWeb News) - PerkinElmer "has reached agreement" with the US Food and Drug Administration, and will resume making and shipping neonatal diagnostic kits at its Norton, Ohio facility, the company said late last week.
Under the agreement, which enables PerkinElmer to immediately restart producing and shipping the chemistry and isoelectric-focusing kits, the company will submit the products to additional undisclosed testing, and offer additional labeling advising proper use.
As GenomeWeb News reported Feb. 5, the FDA had seized the PerkinElmer kits because they 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 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."