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The FDA cited seven drug manufacturers for significant problems identified during inspections, ranging from inadequate testing to a failure to secure analytical equipment. Read More
The FDA hit Hangzhou Guogang Touring Commodity, an OTC drug manufacturer in Zhejiang, China, with a warning letter, for significant problems with equipment cleaning and drug product conformity. Read More
The FDA issued a warning letter to Akorn’s sterile drug manufacturing facility in Decatur, Illinois on Jan. 4 over poor aseptic conditions observed during an inspection last spring. Read More
The FDA released two draft guidances outlining the agency’s latest thinking on assessments of risk evaluation and mitigation strategy (REMS) programs. Read More
The FDA announced that the impurities found in valsartan-containing blood pressure drugs may have been caused by specific chemicals and reaction conditions in the manufacturing process of the drug’s API. Read More
The FDA reopened on January 25 following a 35-day partial shutdown of the federal government that curtailed the agency’s inspection activities that did not directly tie into public safety. Read More
CDER released its latest annual report on drug safety priorities, detailing how it approached drug safety in 2018 — including how it handled the valsartan impurity crisis. Read More
The FDA granted a petition to add warning labels for hypnotic drugs on the risk of injury from falling, but shot down calls for tougher risk assessments by drug sponsors. Read More
The FDA will step up enforcement efforts against stem cell clinics in the coming months, Commissioner Scott Gottlieb told participants at the recent FDLI Enforcement, Litigation and Compliance Conference in Washington, D.C. Read More
The FDA cited Johnson Memorial Cancer Center’s Enfield, Connecticut sterile drug manufacturing facility after investigators found sterility problems, airflow issues and mold contamination during an Oct. 1 to Oct. 19, 2018 inspection. Read More
Contract drug manufacturer Jubilant HollisterStier drew a Form 483 after the FDA observed contamination risks at the firm’s Kirkland, Quebec facility. Read More