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The FDA has issued a warning letter to Indiana Chem-Port, an active pharmaceutical ingredient (API) manufacturer in Gujarat, India, for significant deviations from current good manufacturing (GMP) practices, rendering its products adulterated. Read More
The FDA has issued a warning letter to Innoveix Pharmaceuticals arising from an inspection of the company’s drug compounding facility in Addison, Texas, last May in which an agency official observed serious deficiencies in the plant’s sterile production practices. Read More
FDA investigators observed faulty HEPA filters close to products being manufactured and other quality lapses at Catalent’s Brussels drug facility during an October 2021 inspection. Read More
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