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Quality Systems Issues Take Center Stage In Integra, Hologic Warning Letters

 
• By Elizabeth Orr

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.

Red envelopes around a red exclamation point, with the exclamation point seen through a magnifying glass.
(MMD Creative/Shutterstock)

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.

The 18 December Hologic letter discusses the FDA’s findings during a late-summer 2024 inspection of the company’s Marlborough, Mass., headquarters. The facility makes BioZorb markers, which are currently...

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