PerkinElmer Neonatal IVD Seizure Attributed To Poor Documentation
This article was originally published in The Gray Sheet
Executive Summary
Recent staff turnover at PerkinElmer's Norton, Ohio manufacturing site partly accounted for a failure to address QSR violations that prompted seizure of neonatal screening kits, according to the firm
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PerkinElmer
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)...