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The FDA hit Indian drugmaker Emcure Pharmaceuticals with a warning letter for failing to fully investigate bacterial growth found during batch testing at its facility in Pune, Maharashtra. Read More
A Form 483 issued following an FDA inspection of Novartis subsidiary AveXis’ control testing laboratory — currently the focus of a data manipulation investigation by the agency — is raising concerns about the firm’s own investigation and when it knew about the data discrepancies. Read More
The FDA issued draft recommendations for drug developers on how to make the best use of the agency’s online database of inactive ingredients. Read More
Three U.S. drug manufacturers were hit with warning letters over shortcomings encountered at their facilities, including data integrity concerns, improper equipment calibration and unproven water systems. Read More
A drug manufacturer in Málaga, Spain was cited for failing to test active pharmaceutical ingredients from China and other serious GMP violations. Read More
The FDA hit Puerto Rico drugmaker Caribe Holdings with a Form 483 for not cleaning equipment and utensils at suitable intervals to prevent product contamination and for long delays in validating cleaning procedures. Read More
The FDA hit OTC drugmaker Results RNA with a second warning letter in just over a year, this time for GMP violations at its Orem, Utah facility. Read More
Over-the-counter drug manufacturer Church and Dwight was hit with a Form 483 for violations at its Lakewood, New Jersey facility, including incomplete laboratory records and shortcomings in its microbiological testing. Read More