483
Novo Nordisk Pharmaceutical Industries LPNovo Nordisk Pharmaceutical Industries LP – FDA 483, Aug 29, 2024
Record Details
Novo Nordisk Pharmaceutical Industries LP in Durham, NC, was cited for multiple deficiencies during an FDA inspection. Observations included inadequate environmental controls for API storage, a lack of a comprehensive stability testing program, and insufficient hold time studies. Additionally, the firm failed to follow written procedures for blending alarms, demonstrated inadequate quality control oversight, and had an insufficient shipping validation for its Semaglutide API.
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ID · 69885d7f-9345-48e0-97ea-a22d06fb73a0
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