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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
The FDA now has the power to stop any pharmaceutical import it suspects could be adulterated or misbranded, according to a final rule that implements the agency’s new import authority. 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