Despite boasting a new owner, the Indiana manufacturing plant Novo Nordisk picked up as part of its parent company's Catalent buyout last year continues to catch flak from the FDA. Novo has received ...
Zydus Lifesciences recently received its second Form 483 reprimand from the FDA within the span of one month. In the second write-up, the regulatory agency flagged issues ranging from unqualified ...
Having noticed an uptick in medical device recalls and FDA warning letters to medtech companies this year, it seems an appropriate time to look back on a Form 483 from December 2016 that surprised ...
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