Abbott IVD manufacturing facility reinspection by FDA expected in next few weeks.
This article was originally published in The Gray Sheet
Executive Summary
ABBOTT REINSPECTION BY FDA TO ADDRESS IVD MANUFACTURING DEFICIENCIES is expected to take place in the next few weeks, according to the firm. The reinspection of the company's Abbott Park, Illinois in vitro diagnostic production facilities is intended to verify that Abbott has completed corrective actions taken in response to violations of good manufacturing practices found by FDA during audits in 1993 and 1994. The upcoming inspection will be conducted jointly by FDA's Chicago District Office and centers for devices and biologics.
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