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There is a strong correlation between a surge in warning letters over data integrity issues and increased FDA inspections of manufacturers in India and China — one that could cause production headaches for U.S. drugmakers partnering with these facilities. Read More
A newly released Form 483 faults Indian drugmaker Glenmark Pharmaceuticals for neglecting multiple controls in its procedures at its Pithampur facility. Read More
In the latest of a string of manufacturing snafus plaguing Indian drugmakers, the French National Agency for Medicines and Health Products Safety is calling for the withdrawal of Anuh Pharma’s GMP certificate. Read More
An FDA inspection uncovered a host of GMP deficiencies at a Wockhardt production plant in India, despite earlier attempts by the company to downplay the findings. Read More
Two domestic manufacturers and one in the territory of Puerto Rico have been called out by the FDA over inspection findings covering a diverse array of GMP concerns. Read More
The FDA expects drugmakers to have quality agreements with their suppliers, but how those agreements are crafted says a lot about a company’s internal auditing program. Read More
The FDA slammed Denmark’s Novo Nordisk for numerous GMP issues in a 13-item Form 483 for inadequate controls for sterility, environmental monitoring, labeling and written procedures. Read More
Actavis Laboratories was hit with a two-observation Form 483 after the FDA unearthed potential issues with product storage and recordkeeping. Read More