House Republicans Criticize FDA Foreign Facility Inspections, Agency Publishes More Warnings
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.
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One of firms targeted in eight most recent warnings published since early September to OTC drug manufacturers, Zhao Qing Longda Biotechnology Co. in China, was dinged for both failing to respond to a request for records and for concerns about its production with DEG and EG.
Agency warns two drug firms providing OTC eye drops about failing to maintain sanitary conditions after early in 2023 announcing Indian firm Global Pharma Healthcare made artificial tear products recalled due to potential infection from bacterial contamination not previously seen in US.
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.