PURITAN-BENNETT CLOSING TWO MANUFACTURING FACILITIES UNDER CONSENT DECREE
This article was originally published in The Gray Sheet
Executive Summary
PURITAN-BENNETT CLOSING TWO MANUFACTURING FACILITIES UNDER CONSENT DECREE with FDA signed on Jan. 6. The consent decree orders P-B immediately to cease production and shipment of medical devices from its Boulder, Colorado plant and its FOxS division facility in Carlsbad, California for use in the U.S. until the company "corrects long term, recurring manufacturing problems," FDA said in a Jan. 7 announcement. The Boulder plant manufactures portable home ventilators; the PB 3300 continuous blood gas monitor is manufactured at the FOxS facility.
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