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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
Vipor Chemicals drew a warning letter from the FDA for CGMP violations observed during an inspection last year at its facility in Vadodara, Gujarat — including the use of an API supplied by a manufacturer on an FDA import alert. Read More