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The FDA has rapped Chicago, Ill.-based drugmaker Xeris Pharmaceuticals for a misleading television ad for its diabetes drug Gvoke (glucagon injection). Read More
The FDA cited over-the-counter drugmaker OraLabs for laboratory control lapses and other failures observed during an inspection of its Parker, Colorado facility. Read More
The FDA cited over-the-counter drugmaker Cosmax USA for violations at its Solon, Ohio facility, including training and quality control lapses. Read More
The European Medicines Agency’s suspended the marketing authorizations of generic drugs tested by Panexcell Clinical Laboratories at its site in Mumbai, India. Read More
The FDA hit Las Vegas compounder ACRx Specialty Pharmacy for poor aseptic practices and other GMP failures observed during an inspection last year. Read More
The FDA issued 483s to five drugmakers for inadequate good manufacturing practices observed by agency investigators during inspections of their facilities. Read More
FDA Commissioner Stephen Hahn said that the agency will resume domestic inspections this month using a new risk assessment system developed in response to the pandemic. Read More
The FDA handed Georgia-based contract manufacturer Pharma Tech Industries a Form 483 for good manufacturing practice violations at its Royston facility, including the release of drug products before obtaining test results and insufficient complaint investigations. Read More
Stason Pharmaceuticals did not ensure that capsules of the brain cancer drug temozolomide that it manufactured met dissolution attributes throughout their shelf life, and did not ensure proper computer security for its quality control data, the FDA said in a warning letter. Read More
Signa, a Mexican subsidiary of Canadian generic drugmaker Apotex, has received an FDA warning letter for failure to correct manufacturing problems for active pharmaceutical ingredients (API) that were later released into the U.S. market. Read More