Compliance issues at Integra and Hologic facilities have caught the US Food and Drug Administration’s attention, with the agency publishing lengthy warning letters to both companies on 14 January.
Quality Systems Issues Take Center Stage In Integra, Hologic Warning Letters
The US FDA has published warning letters to device firms Integra and Hologic. Both letters recount quality systems issues, with Integra’s centering on sterility while Hologic’s addresses a delay in noting safety signals from the company’s recalled BioZorb markers.
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