FDA Inspections Triggered More Pharmacy Recalls in 2015
This article was originally published in The Gold Sheet
Agency forces pharmacies to acknowledge they haven't been assuring the sterility of the injectable drugs they compound, spurring recalls and perhaps hope and change for their quality systems.
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As FDA, Congress and the courts stumbled, compounding pharmacies such as NECC took advantage of a gray area of the law. Legislators will get another try; one proposed subjecting such pharmacies to cGMP requirements.
There was greenish-black and white filamentous matter in vials that had been recalled. The question confronting FDA investigators at NECC: How could it have gotten there?
ICH general assembly adopts guidelines on continuous manufacturing and risk management; US FDA opens pilot project to expedite CMC reviews for products with accelerated review timelines; other recent topics include quality maturity inspections and compounding standards.