In a pair of recently disclosed reports, the FDA outlined manufacturing concerns at separate facilities run by China's Hansoh Pharma and Korea's Samsung Biologics.
In China, Hansoh’s sterile drug manufacturing facility was dinged on seven different issues, including inadequate sterilization, during an inspection that took place between April 16 and April 24, 2026. And in Korea, Samsung Biologics was knocked on four different counts based on an inspection at its Yeonsu, Incheon, facility in May 2025.
The FDA issued its concerns to both facilities via a form 483. The write-ups are not the FDA’s final conclusion on a facility and they are less serious than a warning letter.
According to one of the Form 483s, Hansoh could not prove its equipment and clean room were sufficiently sterilized. The sterilization techniques at its facility in Lianyungang, China, were not properly validated. The agency took specific issue with air flow in the facilities clean room and aseptic fill lines which it said had not been properly tested.
The FDA inspectors also noted that the drugmaker did not properly investigate discrepancies or failures of its batches. The FDA flagged recurring gram-negative detections near the injectable manufacturing lines that had never been investigated to find the source.
Hansoh’s cleaning system at the facility was deemed inappropriate in the write-up. The inspectors noted that operators reached over and leaned on equipment during cleaning or used the same cloth to clean multiple pieces of equipment, increasing the risk of contamination.
The firm’s inspection processes were generally found wanting. The FDA came down on Hansoh for failing to perform routine calibrations and inspections of the equipment and said there was no training program, training aids or assessments to ensure inspection staff used consistent technique.
As for Samsung Biologics, its Form 483 was just published late October, but the FDA’s comments were based on an inspection that took place 18 months ago and shared with Samsung in May 2025.
The FDA inspectors noted that the Korean drugmaker did not always follow the prescribed steps for switching between different products, creating critical cross-contamination risks. According to the inspector, this was not a one-time offense. Over the seven years between October 2018 and May 2025, Samsung repeatedly missed the mark on this protocol.
Data falsification was also a repeat concern at the facility. Offenses included a shift leader instructing an employee to falsify data, a quality systems manager trying to identify an employee who had anonymously reported a data integrity issue, and the changing of lot and serial numbers without verification.
This issue has been a feature of past FDA inspections and inspired 56 corrective and preventative actions and 74 change controls to try and address it. Still “data integrity deficiencies have continued” the FDA said.