FDA Sends Warning Letter to Novo Nordisk for Drug CGMP Violations, Threatens Import Refusal
The Food and Drug Administration posted a Dec. 12 warning letter it sent to Novo Nordisk, after finding violations of current good manufacturing practice regulations for the company’s drug products at its Bagsvaerd, Denmark, facility. FDA said it may withhold…
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approval of new applications of supplement listings for the company, and could even deny admission to Novo Nordisk’s drugs manufactured at the offending facility. Novo Nordisk had 15 working days to respond to the letter, which have already elapsed.