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The FDA needs to hire more investigators to conduct overseas inspections to reverse a decline in foreign site visits, the Government Accountability Office (GAO) said in a report released yesterday. Read More
The FDA issued a warning letter to Aurobindo Pharmaceutical after an inspection of the company’s active pharmaceutical ingredient (API) facility in Hyderabad, India. Read More
The FDA has extended its delay on conducting in-person domestic surveillance inspections through Feb. 4 with the goal of restarting the activities as soon as safely possible. Read More
The FDA issued a warning letter to an over-the-counter (OTC) drug manufacturing facility in South Korea following a review of records that raised quality concerns about an acne treatment. Read More
The FDA issued a warning letter to Hubei Kangzheng Pharmaceutical detailing significant violations observed during an inspection of the company’s facility in Hubei Province, China. Read More
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