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Acting FDA Commissioner Ned Sharpless flagged the agency’s increased focus on data integrity violations — and a warning letter sent Tuesday to a Chinese OTC drugmaker over falsified quality control documents. Read More
The FDA found “moldlike” growth and other contaminants at Kumho Dental Pharmaceutical’s over-the-counter dental drug facility in Seoul, South Korea. Read More
Just months after being rapped for violations at its Gardena, California facility, Spectrum Laboratory received another warning letter from the FDA, this time for similar GMP violations at its New Jersey API manufacturing plant. Read More
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