FDA Form 483 issued to Chinese Manufacturer containing some alarming Observations

In January 2024, the FDA conducted an inspection at Jiangsu Hengrui, and the preliminary findings were documented in a Form 483. The FDA criticized Jiangsu Hengrui for a high number of manufacturing defects, delays in the inspection process, deviations during the tour, and the destruction of documents. Specifically, the FDA noted that discarded batch records, validation reports, and change controls did not always align with official archived records, which contributed to delays in the inspection.

During the inspection, investigators observed a large puddle of water and mold-like growth near a condenser in the warehouse. Serious issues in the manufacturing area were identified, including:

- Microbial contamination

- Insufficient media fills

- Poor container closure integrity testing

- Inadequate sterile product controls

- Use of unclean equipment

- Inadequate cleaning validation

- Use of non-approved procedures

- Data integrity problems

No Warning Letter has been issued yet, as Jiangsu Hengrui still has the opportunity to respond, but it is anticipated that a Warning Letter may be forthcoming.