Hologic, Inc. – FDA Warning Letter, Sep 24, 2024

An FDA inspection of Hologic's Marlborough, MA facility from July 30 to September 24, 2024, revealed that their Class II implantable radiographic markers, including the BioZorb product line, are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System regulation (21 CFR Part 820). The inspection also found misbranding violations related to Medical Device Reporting (21 CFR Part 803) and Reports of Corrections and Removals (21 CFR Part 806).

Key violations include: 1) Failure to establish and maintain adequate design control procedures (21 CFR 820.30(a)), with deficiencies in design inputs, verification, validation, and translation to production specifications. 2) Failure to establish and maintain effective corrective and preventive action (CAPA) procedures (21 CFR 820.100(a)(1)), evidenced by insufficient quality data review and inaccurate occurrence rate calculations. 3) Failure to submit Medical Device Reports for serious injuries within 30 calendar days (21 CFR 803.50(a)(1)) for the BioZorb Marker. 4) Failure to submit reports of corrections or removals within 10 working days (21 CFR 806.10) for BioZorb Sizer Set accessory devices.

Hologic has decided to discontinue the BioZorb product line. However, the FDA remains concerned about patients with implanted BioZorb devices and requires the firm to address design-related risks and identify at-risk patients. The firm's responses were deemed inadequate for design control and CAPA, and partially adequate for MDR and corrections/removals. Hologic must provide a written response within fifteen business days detailing systemic corrective actions, including retrospective reviews of other products and complaints, and a timetable for completion, to prevent future violations and avoid further regulatory actions.