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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
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
A new report pushes states to agree on common standards for traditional compounding operations and recommends a series of best practices for all to follow. Read More
A new analysis of state regulatory controls on compounding operations has found significant variance in their oversight and enforcement of traditional compounding operations. 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 has slammed yet another Indian drugmaker for data integrity issues: This time it rebuked Ipca Laboratories for data falsification at three of the company’s manufacturing facilities. Read More
The FDA said its Center for Drug Evaluation and Research and the Office of Prescription Drug Promotion issued 47 warning letters last year, compared with 52 in 2014. 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
Arlington, Texas-based dietary supplement maker Waisted with Lucy was stuffed with violations, as an FDA warning letter dinged the firm for the sale of unapproved and misbranded drugs. Read More
A new report pushes states to agree on common standards for traditional compounding operations and recommends a series of best practices for all to follow. Read More