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The FDA issued its first warning letter under the Drug Supply Chain Security Act (DSCSA), hitting McKesson for violating verification requirements and allegedly shipping illegitimate product. Read More
The FDA issued a series of warning letters to three foreign and two U.S. drugmakers, faulting them for violations ranging from inadequate aseptic processing areas to use of APIs subject to an import alert. Read More
The FDA cited Kadesh International, a Garden Grove, California drug manufacturer, for serious violations observed at its facility including the lack of a quality control unit. Read More
The FDA hit Canadian drug distributor CanaRx with a warning letter, citing the company for supplying unapproved versions of FDA-cleared drugs. Read More
The FDA’s Office of Generic Drugs released its annual report for 2018, highlighting a steady increase in first-time generic approvals and the green lighting of more than 1,000 generic drugs. Read More
The FDA issued a warning letter to an OTC drug manufacturer in Catalonia, Spain, for inadequate testing of released drug products and incomplete batch records. Read More