PerkinElmer
This article was originally published in The Gray Sheet
Executive Summary
Neonatal screening kits produced at the firm's Norton, Ohio plant are subject to additional FDA testing and labeling requirements, per a Feb. 13 agreement with the agency allowing the resumption of production. The plant is slated to shut in approximately six months, with all manufacturing to be consolidated at a Turku, Finland site. U.S. marshals seized nearly $1 mil. in kits Feb. 4, due to a lack of response to QSR violations (1"The Gray Sheet" Feb. 9, 2004, p. 16)...