Abbott awaiting reinspection of TestPack IVD packaging plant under FDA compliance plan.
This article was originally published in The Gray Sheet
Executive Summary
ABBOTT AWAITING FDA REINSPECTION OF TESTPACK IVD PACKAGING FACILITY under a voluntary compliance plan with FDA's Chicago District Office. Reinspection of the company's Abbott Park, Illinois packaging facility for its TestPack lines of in vitro diagnostics is the last step towards FDA verification that Abbott has brought its two Abbott Park IVD plants back into compliance with good manufacturing practices requirements. Abbott hopes that the plant will be inspected before the end of the summer.