Sterilization Failures at Hansoh and Repeat Data Integrity Violations at Samsung Biologics
Hansoh Pharma and Samsung Biologics have received Form 483 inspection reports from the U.S. Food and Drug Administration outlining manufacturing and data integrity concerns at their respective facilities in China and Korea, as reported in recently disclosed documents.
The FDA issued Form 483 notifications, which represent inspection observations rather than final conclusions or formal warning letters. In China, inspectors evaluated a sterile drug manufacturing facility operated by Hansoh Pharma between April 16 and April 24, 2026, citing seven separate issues.
According to the regulatory findings, the Hansoh facility in Lianyungang could not prove its equipment and clean rooms were sufficiently sterilized. Inspectors identified improper validation of sterilization techniques, inadequate airflow testing in clean rooms and aseptic fill lines, and inappropriate cleaning systems where operators leaned on equipment or reused cleaning cloths across multiple units.
Furthermore, the facility failed to perform routine equipment calibrations and lacked training programs for inspection staff. The FDA also noted that Hansoh failed to investigate recurring detections of gram-negative bacteria near injectable manufacturing lines and did not properly examine batch failures or discrepancies.
Seven Years of Protocol Misses at the Samsung Biologics Facility
In South Korea, Samsung Biologics received a Form 483 following an inspection at its Yeonsu, Incheon facility. While the document was published in late October, the agency’s evaluations stemmed from an inspection that concluded 18 months prior in May 2025.
The FDA knocked Samsung Biologics on four different counts, highlighting a pattern of failing to follow prescribed transition steps between different drug products over a seven-year period spanning from October 2018 to May 2025, creating cross-contamination risks.
Data integrity deficiencies also persisted at the Incheon plant. Inspectors documented an instance where a shift leader instructed an employee to falsify data, alongside a quality systems manager attempting to identify an employee who submitted an anonymous report regarding data integrity. Additional offenses included changing lot and serial numbers without proper verification.
These recurring issues have previously triggered extensive internal measures at the Korean drugmaker. Samsung implemented 56 corrective and preventative actions and 74 change controls in an effort to resolve the problems, yet the FDA stated that “data integrity deficiencies have continued.”
