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After nearly 25 years of trying to reach biologics manufacturer Chembiomed but getting no response, the FDA today revoked the Canadian firm’s license. Read More
A recent survey showing that drug company executives are often unaware of problems faced by their quality control units may point to an overlooked contributing factor in FDA warning letters, an expert says. Read More
Toronto-based active pharmaceutical ingredient maker Attix Pharmaceuticals received an FDA warning letter due to lapses in current good manufacturing practices, including failure to appropriately package drug products to avoid cross contamination. Read More
With more than 80 percent of APIs coming into the U.S. from foreign sites, FDA is stepping up its enforcement activities to better manage global supply chains. At the same time, India and China are also expanding their inspection teams. Read More
South Carolina drugmaker Trans Ox was rapped for major deviations in good manufacturing practices and quality controls after FDA investigators found cobwebs on equipment used to analyze drug batches. Read More
Following a series of setbacks that included two failed preapproval inspections and 24 citations, Hospira says the FDA has signaled the all-clear for its new Visakhapatnam, India, manufacturing facility and production is underway. Read More
A federal judge in New Jersey ordered a Hamilton, N.J., company charged with marketing unapproved and misbranded suppositories to destroy its stock and discontinue manufacturing the products. Read More
Toronto-based active pharmaceutical ingredient maker Attix Pharmaceuticals received an FDA warning letter due to lapses in current good manufacturing practices, including failure to appropriately package drug products to avoid cross contamination. Read More