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A Form 483 describes the quality problems that led the FDA to ban imports from Ranbaxy’s Toansa, India plant, with investigators troubled by workers retesting samples until they get acceptable results. Read More
An FDA task force last month recommended the agency expand the amount of information about inspections and enforcement that it releases, allowing the public to view a more detailed record of a company’s compliance history. Read More
Although great strides have been made by Chinese officials to improve the quality of drugs made in the country, more needs to be done, according to U.S. regulators and drug safety advocates. Read More
The FDA has warned another compounding pharmacy for actions that occurred prior to passage of a new federal law that boosted the agency’s authority over such facilities. Read More
The FDA has issued a warning letter to Mexican biologics maker Instituto Bioclon for “significant deviations” of current good manufacturing practices (cGMPs), including failures to ensure adequate environmental monitoring and employee training. Read More
An FDA task force Apr. 22 recommended the agency expand the amount of information about inspections and enforcement that it releases, allowing the public to view a more detailed record of a company’s compliance history. Read More
Indian authorities quietly suspended Ranbaxy’s Toansa facility from exporting active pharmaceutical ingredients to Europe late last month, signaling the country’s new, tougher approach to manufacturing quality violations. Read More
The FDA has banned imports from active pharmaceutical ingredient maker Canton Laboratories, the fourth Indian drugmaker in a month to be put on import alert for poor quality. Read More