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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
The FDA has handed Infusion Options a warning letter for a slew of GMP deficiencies in compounding sterile products and failing to meet 503B conditions for outsourced compounding operations. Read More
Heparin is back in the news, after France’s National Agency for Medicines and Health Products Safety issued a GMP noncompliance statement to China’s Dongying Tiandong Pharmaceutical, which manufactures the active ingredients of Lovenox and Heparin. Read More
The FDA is continuing its nationwide effort to single out compounding facilities that don’t conform to GMP regulations, and it blasted two pharmacies in Florida in recent warning letters. 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