FDA Warns Hologic Over BioZorb Manufacturing Violations

The Food and Drug Administration issued a warning letter to Hologic Inc. 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, the FDA identified several deficiencies related to the production of BioZorb, a class II implantable radiographic marker.

Also Read: Hologic Recalls Soft Tissue Marker Device BioZorb, FDA Issues Warning After Almost 400 Complaints

Key violations included failing to establish adequate design control procedures and maintaining quality system regulations.

The FDA highlighted gaps in design input requirements, verification testing, and validation studies, including the inability to confirm that the BioZorb device appropriately meets its intended use or resorbs in soft tissue.

Complaints of malfunction, including cases where the device did not dissolve for nearly five years, were noted as serious concerns.

Despite discontinuing the BioZorb line, the FDA expressed ongoing safety concerns for patients with implanted devices.

Specific risks include cancer detection interference, radiation treatment complications, and incomplete device resorption. Hologic has yet to address these risks adequately for patients who may require intervention or device removal.

The FDA criticized Hologic’s corrective and preventive action procedures, citing delayed responses to recurring adverse events such as infections, tissue damage, and device migration.

A spike in complaints reported in 2023 went unaddressed until mid-2024, and the company failed to accurately calculate occurrence rates for adverse events.

The letter also flagged lapses in mandatory reporting of adverse events and corrections. Hologic was cited for failing to submit timely Medical Device Reports and corrections under the required timelines.

The FDA has required Hologic to provide a comprehensive corrective action plan within 15 business days, including documentation of steps to prevent future violations.

Failure to comply may result in regulatory actions such as injunctions, product seizures, or civil penalties.

Price Action: HOLX stock is down 0.11% at $69.89 at last check Friday.

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