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The FDA has announced that due to the fast-spreading Omicron variant of COVID-19, it will postpone the planning of prioritized surveillance foreign inspection assignments that were scheduled to begin in February 2022, as well as postponing nonmission-critical work. Read More
The FDA has issued nasal-spray maker Amcyte Pharma of Kirkland, Wash., a warning letter for marketing an unapproved and misbranded product related to COVID-19. Read More
Novartis Gene Therapies’ Libertyville, Ill., plant, which produces Zolgensma — the world’s most expensive drug at more than $2.1 million per treatment — has drawn a Form 483 with five observations during a June 8-16 inspection by the FDA. Read More
The agency officials also observed problems with the physical plant. The production room, for example, had reoccurring roof leaks that impacted two batches of drug product. Read More
FDA investigators observed numerous quality failures during an inspection of a KVK Tech generic drug manufacturing facility in Newton, Penn., ranging from lax cleaning to incomplete investigations of complaints. Read More
A global coalition of regulators has recommended permanent use of the remote inspections of drug manufacturing plants that regulatory bodies began to use during the COVID-19 pandemic. Read More
Spartan Chemical didn’t conduct validation studies for the water system used to manufacture drug products, among other quality lapses observed during a recent FDA inspection of the company’s Maumee, Ohio facility. Read More
Dercher Enterprises of Upper Darby, Pa., doing business as Gordon Laboratories, was hit with an eight-observation Form 483, and the company’s new quality director told FDAnews that he’s working to pull the company into full compliance. Read More
The Guyer Institute of Molecular Medicine, an Indianapolis, Ind.-based drug compounder, has drawn a warning letter from the FDA for its sterile drug production. Read More
The FDA issued an update on its inspection performance for fiscal 2021, indicating that it had surpassed its projections for completed inspections by more than 30 percent due to new approaches introduced during the pandemic. Read More
The pandemic forced the FDA to be far more innovative in its efforts to inspect drug manufacturing facilities, and the agency plans to incorporate these new modalities into its site surveillance process going forward. Read More