On March 9, 2026, the Food and Drug Administration (FDA) published a draft guidance, “Responding to FDA Form 483 Observations at the Conclusion of ...
Amid the company’s efforts to resolve issues raised during an FDA inspection early last year, Novo Nordisk’s operating base in Plainsboro, New Jersey—already the recipient of a recent Form 483—has ...
Compliance & Enforcement Team explores the U.S. Food and Drug Administration’s new draft guidance on responding to FDA Form 483 ...
COPENHAGEN, March 10 (Reuters) - Novo Nordisk said on Tuesday it had received a warning letter from the U.S. Food and Drug Administration regarding an inspection at the Danish drugmaker's site in ...
Last week, Zydus Lifesciences confirmed the receipt of an FDA warning letter at its Waghodia plant in Gujarat, India, marking the latest in a string of production reprimands for the Indian drugmaker.
Novo Nordisk has responded to a "warning letter" which claims the pharmaceutical giant didn't report adverse side effects, or ...
The FDA has made additional reports on inspections of ByHeart infant formula plants available. The company’s formula has been determined to be the source of at least 37 cases of infant botulism. The ...
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