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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 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
Dietary supplement maker TJM Resale’s Synaptik Supplements & Ligand Solutions was slapped with an FDA warning letter over the sale of unapproved and misbranded drugs. Read More
A December FDA warning letter to China’s Zhejiang Hisun Pharmaceutical outlines the company’s “systemic data manipulation” and cGMP deficiencies uncovered during a March 2015 inspection. Read More
The UK’s Medicines and Healthcare products Regulatory Agency GCP Inspectorate conducted 125 GCP inspections between April 1, 2013, and March 31, 2014, yielding only two critical findings and 56 major findings among 22 commercial sponsors, according to the agency’s GCP Inspections Metrics Report. Read More
The FDA has handed warning letters to three supplement makers for GMP issues such as improper storage and undeclared ingredients, as well as implied marketing for pharmaceutical indications. 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
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