Marlborough device maker receives FDA warning regarding implantable devices
Hologic Inc. has received a warning letter from the Food and Drug Administration regarding its BioZorb product line, even ...
Hologic receives FDA warning letter over Biozorb implantable markers
Hologic stopped manufacturing the device after reports of serious adverse events in patients who had the markers implanted in breast tissue.
Plastics News1d
FDA warns Hologic to do more to prevent harm from component in recalled implant markers
The U.S. Food and Drug Administration has sent a warning letter to Marlborough, Mass.-based medical technology company ...
FDA Warns Hologic Over BioZorb Manufacturing Violations
FDA issues warning to Hologic, citing manufacturing and safety violations for BioZorb devices. Patient safety risks and reporting failures highlighted ...
medtechdive3d
Hologic receives FDA warning letter over Biozorb implantable markers
The warning letter follows an FDA inspection of Hologic’s Marlborough, Massachusetts, headquarters between July 30, 2024, and Sept. 24, 2024. The FDA raised concerns that Biozorb’s device design did ...
healthcarepackaging4d
Appropriate Steps to Avoid And Answer FDA Warning Letters in 2025
The rate of warnings initiated by the FDA continues to rise in the pharma and medical device industries. Knowing how to best ...
JD Supra3d
Complete Response Letter, Warning Letter and Shareholder Lawsuit Follow FDA Data Integrity Findings
Applied Therapeutics, a clinical-stage biopharmaceutical company, is under heightened scrutiny following the issuance of a November 2024 ...
Food Safety News6d
FDA warns companies about lead contamination and other violations
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months ...