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FDA Warns Hologic Over BioZorb Manufacturing Violations - Hologic (NASDAQ:HOLX)

Summary by Benzinga
The Food and Drug Administration issued a warning letter to Hologic Inc. (NASDAQ:HOLX), citing violations in the manufacturing and reporting processes for its BioZorb product line. The letter, addressed to CEO and President Stephen MacMillan, outlines significant compliance concerns that have prompted the company to discontinue the product. During an inspection from July 30 to Sept. 24, 2024, at Hologic’s Marlborough, Massachusetts, facility, th…
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