Contamination Issues Drove Drug Recalls to Record Levels in 2011
This article was originally published in The Gold Sheet
How contamination, sterility assurance, OOS and other issues caused drug recalls to spike again last year. What happened at Aidapak, H&P, Ben Venue, Hospira, Teva and other manufacturers to set a new record.
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Agency says compounding pharmacies are more familiar with standards and methods for producing drug products than “untrained consumers.” It will allow operations that might otherwise get sanctioned for marketing adulterated drugs because their products likely are better than some remedies consumers are making. It is aware consumers are experiencing difficulties accessing alcohol-based hand sanitizers and are concocting their own hand sanitizers.
Agency refrains from enforcing certain FD&C Act requirements against compounders who prepare alcohol-based hand sanitizers during COVID-19 public health emergency.
Many of the 30 drug product firms that received FDA warning letters in 2016 were foreign cosmetics and hygiene manufacturers that appeared to need education on US GMP requirements. Another major focus in letters to drug product firms last year was sterility assurance in the US and abroad.