Search Results for Baxter

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FDA Allows Temporary Saline Imports to Deal With Shortages Caused by Hurricane Maria By Zachary Brennan - Published 11 October 2017

Baxter Healthcare said in letters to health care professionals dated Monday that it is working with the US Food and Drug Administration (FDA) to import sodium chloride and glucose intravenous infusion products from Ireland and Australia to address shortages because of Hurricane Maria.

Categories: News, US, FDA, Crisis management, Drugs, Regulatory intelligence, Regulatory strategy

Tags: Baxter, drug shortages, Puerto Rico, Hurricane Maria

Health Canada Outlines 2016 Deficiencies at Actavis, Sanofi, Gilead and Other Manufacturing Facilities By Zachary Brennan - Published 05 February 2016

As part of Health Canada’s transparency push, the regulator is unleashing new information about its work, including an updated good manufacturing practice (GMP) inspection database that reveals new GMP deficiencies for Actavis, Sanofi-Aventis, Gilead, Baxter and other manufacturing facilities from inspections conducted in January 2016.

Categories: News, Canada, Health Canada, Audit, Biologics and biotechnology, Compliance, Drugs, Manufacturing, Medical Devices, Quality

Tags: Health Canada, Gilead, Sanofi, Actavis, Baxter, GMP inspections

Facing Dire Shortage of IV Saline, FDA Again Turns to Enforcement Discretion Approach By Alexander Gaffney, RAC - Published 30 April 2014

Categories: US, FDA

Tags: Shortage of Saline, IV Saline, Saline, Baxter, Enforcement Discretion, Drug Shortage, Latest News, Drug Shortages

GMP Deficiencies in Spotlight in Warning Letters to Amgen, Baxter By Alexander Gaffney, RAC - Published 11 February 2014

Categories: US, FDA

Tags: 21 CFR 820, Baxter, Amgen, warning letter, Latest News, GMP