Search Results for Field Alert Reports

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FDA Offers Updated Form for Field Alert Reports By Michael Mezher - Published 16 June 2017

The US Food and Drug Administration (FDA) on Thursday released an updated version of its automated Field Alert Report (FAR) form, following the conclusion of a successful four-year pilot program.

Categories: News, US, FDA, Generic drugs, Prescription drugs, Postmarket surveillance

Tags: FAR, Field Alert Reports

FDA Warns B. Braun Medical’s California Plant for Repeat Violations By Zachary Brennan - Published 31 May 2017

The US Food and Drug Administration (FDA) earlier this month sent a warning letter to B. Braun Medical’s Irvine, CA-based manufacturing facility for repeat violations also uncovered during inspections in 2013, 2014 and 2015.

Categories: News, US, FDA, Drugs, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: B. Braun Medical, FDA warning letters, field alert reports, leaking IV bags