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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
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
British authorities continue to investigate 21 cases of blood poisoning in babies who received potentially contaminated batches of an intravenous liquid feed at neonatal intensive care units in England, but said the manufacturer of the product was following GMP guidelines. Read More
Alexion is pulling more of its flagship product Soliris from the market due to visible particles that arose from a manufacturing problem, the third recall in less than a year. Read More
The FDA expects to start collecting manufacturing quality metrics data from drugmakers sometime in 2015, a move agency officials say will cost manufacturers little but pay off in the potential for fewer inspections. 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
The FDA Tuesday 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. The second finalizes draft enforcement guidance spelling out what enforcement smaller, traditional compounders can expect from the agency. Read More
The FDA chided positron emission tomography (PET) drug manufacturer IBA Molecular North America for not properly handling complaints and quality production. 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