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A drug manufacturer in Bangalore, India, drew a warning letter from the FDA for failing to properly investigate contamination at its facility. Read More
The FDA rapped an AbbVie manufacturing facility in Barceloneta, Puerto Rico, for good manufacturing practice failures, including missing written procedures. Read More
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