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An FDA remote inspection can carry major drawbacks, including that they may last longer than an in-person visit and that the FDA doesn’t consider them to be a full substitute for an on-site inspection. Read More
An FDA inspection of Regeneron Pharmaceuticals’ active pharmaceutical ingredient (API) manufacturing facility in Rensselaer, N.Y., turned up observations of lapses in recordkeeping and cleaning procedures. Read More
The FDA is not ruling out further use of remote assessments for Good Clinical Practice (GCP) inspections postpandemic, but the agency is clear: the bulk of its inspection activity will remain onsite despite more remote-based approaches catching on elsewhere. Read More
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