Hologic received an FDA warning letter concerning its Biozorb implantable markers, a significant regulatory action. The company had already ceased manufacturing the device following reports of serious adverse events in patients who had the markers implanted in breast tissue.
The warning letter indicates that the FDA identified issues related to the device. This development highlights potential compliance challenges and product safety concerns within the company's operations.
The cessation of manufacturing and the FDA's warning could impact Hologic's reputation and may lead to further scrutiny or financial implications related to product liability.
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