Chinese Firm Hit With Pandemic's First Remote-Records-Based FDA Drug GMP Warning Letter
Import alert and warning letter came after Ningbo, China, over-the-counter skin care products firm failed to share requested testing records.
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Product sampling and remote records requests accounted for most import alerts and drug GMP warning letters over the past year – and may play key role post-pandemic.
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.
FY2020 review highlights drop in inspections, preparations for growing backlog, and pandemic test of Janet Woodcock’s 21st Century proposition – developments that will likely reverberate in the years ahead.