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The agency said that personnel with knowledge of the firm’s market withdrawals, submissions and design controls were not present during the inspection to explain the basis for the market withdrawal of a pregnancy test. Read More
Complaints of software-related performance problems did not go through the firm’s complaint handling procedure, which meant they were not evaluated to determine if the events should be reported to the FDA. Read More
The procedure didn't require all service records to be evaluated for potential complaints, and the firm had not conducted the procedure since 2016. Read More