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.…
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. Source:…
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.…
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…
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,…
Contract drug manufacturer Jubilant HollisterStier drew a Form 483 after the FDA observed contamination risks at the firm’s Kirkland, Quebec facility. Source: Drug GMP Report
The FDA hit Vital Laboratories with a Form 483 for incomplete batch production records, inadequate complaint handling and unapproved labeling, among other violations, at its Vapi, Gujarat facility. Source: Drug…
The FDA hit Korean drug supplier Barox with a warning letter for quality control, drug labeling and product storage issues at its Seongnam, Gyeonggi facility. Source: Drug GMP Report
A Florida class-action suit charges Walmart, Aurobindo Pharma, ScieGen Pharmaceuticals and Westminster Pharmaceuticals negligently allowed potentially carcinogenic blood pressure drugs onto the market. Source: Drug GMP Report
Indian drug manufacturer SkyLark CMC drew a warning letter from the FDA by denying the agency investigator access to its manufacturing facility in Ahmedabad, Gujarat. Source: Drug GMP Report