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

28 Jan 2021

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...