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Chinese Firm Hit With Pandemic's First Remote-Records-Based FDA Drug GMP Warning Letter

 
• By Bowman Cox

Import alert and warning letter came after Ningbo, China, over-the-counter skin care products firm failed to share requested testing records.

Coronavirus prevention medical surgical masks and hand sanitizer gel for hand hygiene corona virus protection.
records failed to demonstrate hand sanitizer quality

In the first of what could be many as pandemic travel restrictions continue, the US Food and Drug Administration on 22 January issued a drug good manufacturing practices warning letter to a company in China that was based on a remote records request rather than a site inspection.

It was 31 March 2020, two months after the FDA evacuated its China office and two weeks after it suspended travel for all but “mission-critical” foreign and domestic inspections, when the agency issued a request for certain records

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