“Alarming” Number of US FDA Recalls Attributed To Equipment Breakdowns
Sanofi Describes Its Proactive Approach To Maintenance
Agency urges pharmaceutical industry to be proactive on equipment monitoring. Sanofi efforts include an interdisciplinary approach to equipment inspections.
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FDA Warns Consumers Not To Use Sterile Drugs Made By Pacifico National After Firm Refuses Recall Requests
After Melbourne, Florida, outsourcer resisted entreaties to recall sterile drugs over contamination and eye infections, the FDA warned consumers not to use sterile drugs compounded by the firm, Pacifico National, doing business as AmEx Pharmacy.
Aurobindo failed to properly investigate problems with carcinogenic impurities in active pharmaceutical ingredients, warning letter says.
Action responds to methanol contamination in hand sanitizers manufactured in Mexico and marketed in the US under numerous brands that followed a loosening standards for the products to drive a swift increase in production and meet surging demand during the coronavirus pandemic.