The Quality Lowdown: More Inspection Delays, More Findings On Sterility And Investigations
US FDA hits firms in New Jersey, South Korea and China with warning letters. Meanwhile, Catalent and several outsourcing facilities work on Form 483 inspection findings as Mylan, Viona and Lohxa announce drug recalls.
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Agency’s revised OOS guidance clarifies positions on outlier test results, averaging of HPLC results and some finer points around OOS questions. These could marginally improve compliance but won’t impact industry with nearly the force of the original 2006 guidance or the 1993 court ruling that preceded it.
While pharmaceutical manufacturing facilities can age well, the care and attention aging facilities require can arise at inopportune moments, as was the case for Novo’s Wegovy launch. Even so, Catalent aims to make quick work of air handler replacement to get the new weight-loss drug back into production, despite typically long lead times, consultant says.
With a virtual visit to SciVac in Israel, a belated Revance site inspection in California and two weeks at a Dr. Reddy’s site in India, the US FDA finds ways to overcome travel restrictions in its efforts to oversee drug manufacturing quality.