Another FDA 483 highlighting critical data integrity failures at a sterile manufacturing site in India.
A recent U.S. Food and Drug Administration 483 inspection at Maiva Pharma Pvt. Ltd. (Hosur, Tamil Nadu, India) identified serious deficiencies in the control of original CGMP manuf
FDA Issues Warning Letter to Novo Nordisk Inc. Regarding Postmarketing Safety Reporting
The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to Novo Nordisk Inc. (NNI) following an inspection conducted between January and February 2025. The inspecti