US Still Rinsing Out OTC Sanitizer Warnings
Of GMP warnings for OTC hand sanitizers, 114 have been submitted by FDA since pandemic began, with first sent in late April 2020, and another 12 for false COVID-19 claims, with first sent on 1 April. One GMP warning for hand sanitizer product is listed in both 2018 and 2019.
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Oversight and Investigations Subcommittee conducts hearing as subcommittee chair Morgan Griffith and Energy and Commerce chair Cathy McMorris Rodgers leave no doubt they give FDA failing grade on foreign inspections. Five foreign facilities among firms in FDA’s latest warnings.
Agency’s latest posting of warning letters submitted also includes more warnings about OTC hand sanitizer production failing to meet GMP requirements.
“The nonprescription drug space has been a bit challenging over the past two to three years as a result of the pandemic,” says CDER director Patrizia Cavazzoni.