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The Federal Court of Canada has quashed Health Canada’s import ban on drugs from two Apotex facilities in India, saying the agency proceeded unfairly. Read More
Despite being closed for more than a year, OTC drugmaker American Family Pharmacy was hit with an FDA warning letter for a litany of cGMP violations, including failing to follow quality control procedures, lacking production and process control procedures and having misbranded drug products. Read More
The FDA issued eight warning letters to active pharmaceutical ingredient manufacturers during fiscal year 2015 — all of them to non-U.S. companies and all for data integrity issues. Read More
A Texas drug compounder is recalling all lots of its sterile drug products after an FDA inspection found it had not investigated failed sterility tests. Read More
Observations cited in a Form 483 need to be carefully reviewed, because they represent — at least in the mind of that investigator — conditions that could make a drug adulterated. Read More
The FDA hit another Indian active pharmaceutical ingredients maker with a warning letter after an inspection revealed data integrity issues and significant cGMP violations. Read More
The FDA handed Baxter Healthcare a six-observation FDA Form 483 for lapses in sterile process controls and failure to review batch discrepancies at its Puerto Rico manufacturing plant. Read More
Novartis’ generics unit Sandoz received a warning letter from the FDA citing cGMP deficiencies for finished drugs at the company’s plants in Kalwe and Turbhe, India. Read More
The FDA handed SSM Health Care a warning letter for GMP deficiencies in compounding sterile drug products as well as failure to follow 503B conditions for outsourcing facilities at its Fenton, Mo., facility. Read More
The FDA’s program alignment will see district offices and laboratories focus only on one category of products, primarily designated by geographic location and the types of industries that surround those locations, FDA Acting Commissioner Stephen Ostroff said. Read More