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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.