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The Indian government is offering a reward to whistleblowers who provide information leading to the seizure of spurious, adulterated and misbranded drugs. Read More
Baxter is voluntarily recalling four lots of intravenous solutions in response to customer complaints of plastic and fiber particles in the product, its fourth recall this year related to particulates. Read More
The FDA has slapped a warning on an Italian active pharmaceutical ingredient manufacturer for deleting quality data, the latest indication the agency is serious about clamping down on poor manufacturing data integrity. Read More
Indian generics maker Sun Pharmaceutical is voluntarily recalling 41,127 bottles of the antidepressant venlafaxine HCl extended-release tablets over improper dissolution. Read More
Hospira conducted its fourth recall in roughly two months due to contaminated products, leading to another quality headache for the injectables giant. Read More
The FDA released two major guidances for compounding pharmacies. One establishes for the first time an interim GMP framework for large compounders that register with the agency as outsourced facilities. Read More
The FDA warned another compounding pharmacy for mixing unapproved drugs and for poor quality, with Pharmacy Creations becoming the latest compounder to challenge agency enforcement of its activities. Read More
GlaxoSmithKline’s vaccine plant in Canada received an FDA warning for a bevy of quality violations such as failing to prevent contamination in its manufacturing processes and water system. Read More
Canadian generics maker Apotex’s Bangalore, India, plant has rampant problems with data manipulation, including continuously retesting batches until the desired result is achieved, the FDA charged in a warning letter. Read More
Faulty lab coats, hairnets and facemasks were among the problems cited in a warning letter to compounding pharmacy Medaus, the latest compounders to receive a warning from the FDA. Read More
Tianjin Zhongan Pharmaceutical’s manufacturing facility in China failed to follow cleaning procedures and maintain records on equipment operations, according to an FDA warning letter that cites various GMP violations. Read More
Injectables maker Hospira is facing yet another recall after a customer found particulates embedded in a vial of 0.5 percent Marcaine painkiller. Read More