Regulatory Oversight in Drug Compounding on the Rise
Drug compounding until very recently has had a lot looser regulation than that of pharmaceutical drugs. The looser regulations served a real function: It allowed people who need a very specific drug formulation that was not available in a widely manufactured product. This could include discontinued drugs or specific forms of current drugs that do […]
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Indian Company Pan Drugs Redoing API Program After FDA Warning Letter
Pan Drugs in India got an FDA warning letter this week, with the federal agency citing the company for several GMP problems. The facility is located in Nadesari, Vadodara. FDA stated that the company did not maintain, repair and keep its API manufacturing units clean. FDA noted that there were holes in the roof and […]
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Canada Hits Dr. Reddy’s With Import Ban
Indian drug manufacturers are now coming under tough scrutiny of Canadian drug regulators. Health Canada this week stated that Canadian importers of drugs are putting an import ban on drug products from Dr. Reddy’s Laboratories, as well as IPCA Laboratories. Health Canada stated that Canadian drug importers are quarantining health care products from these two […]
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Impax Hit With Another FDA 483
Impax Laboratories was hit with its second FDA 483Â recently on its plant in Hayward CA. This follows an inspection and 483 for its plant in Taiwan earlier this year. This latest 483 came just a few months after Impax stated that it was confident that its manufacturing processes were good enough to resubmit an […]
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FDA Making Changes to Drug and Manufacturing Oversight
FDA Commissioner Margaret Hamburg, MD, is seeking new ways for the agency to deal with its complex regulatory roles, especially as it pertains to drugs. In 2013, Hamburg came up with a new agency wide organization to make key recommendations to improve how FDA centers deal with its audit employees. The result of that effort […]
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FDA Studies Drug Inspections Using Drone Technology
FDA is looking into the use of airborne drones to help it to conduct cGMP inspections of drug and device facilities. There is not any formal drone program in place or being developed, FDA is looking at the feasibility of using drones for certain drug inspection applications. If FDA decides to use drones for FDA […]
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FDA Warning Letter Hits Sun Pharma for Hiding Batch Failures
A warning letter for a now banned Sun Pharmaceutical plant in India, posted today by the FDA, shows employees routinely deleted records of batch failures then retested drugs, reporting they met the standards that they previously couldn’t hit. In fact, FDA inspectors fished torn and partially destroyed raw data cGMP records out of the trash. […]
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FDA Slams US Wockhardt Plant With 483
FDA issued a Form 483 listing possible violations of the Food Drug and Cosmetic Act after inspecting Wochardt’s drugmaking facility in Morton Grove, Illinois, over seventeen days between January and March, according to a document on the agency’s website. Two of the Mumbai-based drugmaker’s Indian facilities are already banned from exporting to the U.S. after […]
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FDA Hits Wockhardt US Plant for Using Same Bad Tests as In India
FDA has lashed out at India’s Wockhardt, saying a plant in the U.S. was using the same questionable drug-testing procedures that led the agency to ban two of Wockhardt’s Indian plants last year. The observation is one of a dozen cited in a Form 483 the FDA has issued to Wockhardt’s Morton Grove Pharmaceuticals plant, […]
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FDA Must Act on Sunscreen Ingredients
Those feel like you’re getting sunburned quicker or more often than in years past, those people are probably right. The sun is getting stronger, but the protection offered by our sunscreens in the U.S. isn’t keeping up. It’s been 15 years since the FDA approved new ingredients for use in sunscreens. With one person dying […]
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