Hologic, Inc.

Warning LetterOpen

Stephen MacMillan CEO/President Hologic, Inc. 250 Campus Drive Marlborough , MA 01752-3020 United States Steve.MacMillan@hologic.comFEI 2024800Issued Dec 18, 2024Center for Devices and Radiological Health

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 2024800.

Violations9

Issue DateDec 18, 2024

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: Hologic, Inc.
Location: Stephen MacMillan CEO/President Hologic, Inc. 250 Campus Drive Marlborough , MA 01752-3020 United States Steve.MacMillan@hologic.com
FEI Number: 2024800
Country: United States
Issue Date: December 18, 2024
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Summary

Hologic, Inc. was cited for manufacturing class II implantable radiographic markers (BioZorb product line) in violation of current good manufacturing practice requirements under 21 CFR Part 820. The FDA inspection from July-September 2024 identified critical design control failures, including the company's failure to implement established Design Control Procedures and related SOPs to ensure specified design requirements were met. The company subsequently decided to discontinue the BioZorb product line following these findings.

Hologic, Inc. FDA Warning Letter, December 18, 2024