US FDA warning letters related to good manufacturing practices more than doubled in 2016 as the agency continued to crack down on a lack of sterility assurance in domestic pharmacy compounding and a lack of data integrity in foreign active pharmaceutical ingredient manufacturing, and addressed a lack of basic GMP compliance among foreign over-the-counter drug manufacturers.
FDA issued 110 drug GMP warning letters in calendar year 2016, matching a record set in fiscal year 1995 (Also...
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