Manufacturing Compliance Updates In Brief: Dasan, Akorn, Evertogen And 10 Others
Executive Summary
Dasan didn't test glycerin for DEG; Akorn didn't see the problem with washed-vial conveyor belt crumbs; Evertogen was undone by a desk audit; six unsanitary compounders were warned; four firms were hit with drug GMP import alerts.
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Manufacturing Compliance Updates In Brief From US FDA And EU
Many of the six drug GMP warning letters the US FDA has issued since late March targeted lax testing practices, particularly at OTC firms abroad. Two EU GMP non-compliance notices highlighted data integrity shortcomings in India. FDA also posted a couple of Form 483 reports and added four facilities to its GMP import alert.