FDA Form 483 to Chinese Manufacturer with some alarming Observations

The FDA carried out an inspection at Jiangsu Hengrui in January 2024. The initial findings have now been published in a so-called Form 483.

In this document, the FDA reprimanded Jiangsu Hengrui for an above-average number of manufacturing faults, but also for delays of the inspection, detours during the tour and the destruction of documents. The FDA described this process in a separate observation, noting that discarded batch records, validation reports and change controls did not always match archived official records. This attempt at ultimately delayed the entire inspection, according to the letter.

During the agency's inspection, FDA investigators noticed a large puddle of water on the floor of a warehouse and black mould-like growth on the floor near a condenser.

The observations in the manufacturing area pointed to a number of very serious problems, for example:

• Microbial contamination
• Insufficient media fills
• Inadequate container closure integrity tests
• Inadequate controls of sterile products
• Use of dirty equipment
• Insufficient cleaning validation
• Use of non-approved instructions
• Problems with data integrity
• And (unfortunately) much more

Details can be found in the document.

A Warning Letter has not yet been issued, as the company still has the opportunity to comment. However, it seems unlikely that this will not be issued.