The U.S. Food and Drug Administration (FDA) has issued a Form FDA 483 identifying multiple manufacturing and quality-control deficiencies at the sterile drug manufacturing facility of Jiangsu Hansoh Pharmaceutical Group Co. Ltd. in Lianyungang, Jiangsu, China.
The observations followed an FDA inspection conducted between April 16 and April 24, 2026. The inspection report, addressed to Fred Lu, Head of Products Division (Vice President), outlines seven major observations concerning aseptic manufacturing practices, contamination prevention, sterilization validation and pharmaceutical quality systems.
One of the most significant observations involved inadequate validation of sterilization processes and procedures intended to prevent microbiological contamination of products labeled as sterile.
FDA investigators identified deficiencies in airflow visualization studies, media fill simulations and decontamination validation for aseptic processing areas. The agency also noted that certain sterilization processes for equipment in direct contact with drug products had not been adequately validated.
The FDA highlighted concerns regarding the company's investigation of unexplained discrepancies and batch failures.
According to the inspection report, certain investigations lacked sufficient depth, including inadequate examination of manufacturing-related factors, insufficient assessment of retained samples and limited involvement of the Quality Unit in reviewing production equipment and process records.
The agency also identified concerns regarding the investigation of environmental monitoring results and recurring gram-negative microbial recoveries in manufacturing areas.
Additional observations focused on deficiencies in aseptic processing techniques and the company's ability to maintain sterile manufacturing conditions. Investigators noted examples of operator practices that could compromise aseptic operations, including blocking first air during stopper addition, reaching into restricted areas of restricted-access barrier systems (RABS), and inadequate handling of equipment during manufacturing interventions.
The FDA also identified shortcomings in visual inspection qualification programs for sterile injectable products, raising concerns about the ability of inspectors to consistently detect particulate matter and other defects.
The inspection report identified weaknesses in environmental monitoring programs, including gaps in monitoring certain manufacturing activities and locations.
The FDA further observed that cleaning and disinfection procedures for rooms and equipment were inadequate to consistently maintain aseptic conditions. Specific concerns included cleaning practices, reuse of cleaning materials and insufficient disinfection procedures for critical manufacturing equipment.
The agency also raised concerns regarding routine calibration and performance verification of manufacturing equipment. Deficiencies included inadequate verification of weighing systems, insufficient checks of equipment designed to reject overfilled and underfilled vials, and gaps in the validation of in-process inspection methods. The report additionally questioned whether certain analytical and testing procedures had been adequately validated.
The Form FDA 483 identifies seven principal observations covering :
1. Inadequate validation of sterilization processes.
2. Failure to thoroughly investigate unexplained discrepancies and batch failures.
3. Insufficient procedures to prevent microbiological contamination.
4. Deficiencies in environmental monitoring systems.
5. Inadequate cleaning and disinfection procedures.
6. Inadequate calibration and inspection of manufacturing equipment.
7. Insufficient validation of in-process manufacturing controls and testing methods.
The inspection findings highlight the importance of robust current Good Manufacturing Practice (cGMP) systems, particularly for sterile injectable drug manufacturing, where contamination-control failures can create significant risks to product quality and patient safety.
A Form FDA 483 communicates inspectional observations to a company's management. It does not, by itself, represent a final FDA determination of regulatory compliance or establish that specific products are defective.
The company will need to evaluate the observations and implement appropriate corrective and preventive actions (CAPA) to address the identified deficiencies.
