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Propofol Shortage Follows Teva and Hospira Warning Letters and Recalls

European manufacturer Fresnius is stepping in to help fill the US shortage in the injectible anaesthetic propofol caused by GMP problems at Teva and Hospira, resulting in warning letters and recalls. FDA's lengthy warning letter to TEVA in December, posted in April, focused on the manufacture of their generic version of propofol, and primarily related to microbial contamination and testing, including endotoxin in distributed product....

MHRA is Requiring Interim Update Reports for Risk-Based Inspections

MHRA is requesting that all manufacturing sites inspected after April 1, 2009 under its risk-based inspection (RBI) approach submit interim updates to communicate significant changes between inspections....
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