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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
Inspections at beleaguered Indian generics firm Wockhardt’s Illinois plant have turned up quality control issues ranging from poor cleanliness to shoddy product testing and incomplete recordkeeping, the FDA says. 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
The FDA and Customs and Border Protection last month began accepting applications for an 18-month pilot of a “trusted trader” program to reduce inspections and oversight of imports from drugmakers that establish tough internal import control programs of their own. Read More
Regulators pushing for greater international cooperation cautioned that relying on other countries’ inspections would require overcoming crucial hurdles such as incompatible technology, language barriers and keeping trade secrets secret. Read More
It took Luitpold Pharmaceuticals subsidiary PharmaForce in some instances months to close investigations into out-of-specification results, leading to a Form 483 from the FDA. Read More
Inadequate validation studies and complaint investigations resulted in a new Form 483 for Hospira, which has struggled with quality issues over the past few years. Read More
With a deadline looming, the pharmaceutical industry still needs to decide which data systems are most efficient and cost-effective for implementing the federal track-and-trace law, experts say. Read More