Deadly COVID-19 Hand Sanitizer Production Surge Prompted US FDA's New Import Alert Category
New import alert category and border testing required after reduced standards put dangerous sanitizers into hands of US consumers.
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Selective whistleblower allegations, investigative reports hint at drug GMP issues awaiting US FDA inspection resumption; GSK sotrovimab EUA gets root cause provision; API GMP compliance work acknowledged; Aziyo recalls bone matrix associated with tuberculosis outbreak, and other matters in this latest update.
PCCA repackaged adulterated APIs, Allay failed to understand processes, ShangRao and Mexican firms peddled subpotent, sometimes methanol-tainted ethanol.
Compared to FY2019, FDA data show agency inspections of OTC and Rx drug manufacturing facilities in FY2020 fell 60%. As pandemic continues in FY2021, inspection rate will remain depressed, and it remains unclear how the agency will reduce the backlog without resorting to remotely conducted inspections.