FDA Sears China’s Hengrui In Recent 483
June 23rd, 2024 // 12:54 pm @ jmpickett
When the FDA comes to your cGMP drug manufacturing facility, it is best to cooperate with them. However, Jiangsu Hengrui Pharmaceuticals in China decided not to play along and it cost them.
The May FDA 483 criticized Hengrui for a long list of cGMP and manufacturing errors, such as subpar contamination controls, inadequate cleaning protocols, and not handing documentation over to FDA auditors promptly.
FDA did its inspection of Hengrui’s manufacturing facility in Lianyungang, China, in January 2024. The agency posted the 483 on its website last month.
News of the FDA citation came a few weeks after Hengrui and Elevar Therapeutics received FDA rejections on their drug applications for PD 1 inhibitor camrelizumab and the VEGFR inhibitor rivoceranib. The two companies had hoped they would be approved simultaneously for treatment for liver cancer. However, the 483 is unrelated to the rejected drug applications.
One of the most significant violations noted in the 483 was the company didn’t make production records available to FDA auditors. FDA staff said in the 483 that they were guided on a longer route to delay their arrival at the place where the company gets rid of office waste. Once the team got to the waste bins, FDA auditors saw a worker quickly putting documents in the trash bin. Other individuals watched this action, with one of them having ripped up documents in hand.
FDA detailed what those documents contained in another 483 observation. It stated that discarded validation reports, batch records, and change controls failed to regularly match official records in the archive.
The agency further stated that injectable drug products that were supposed to be destroyed in the waste area were not secure. The firm also was criticized for not establishing proper sterilization processes to avoid microbiological contamination and not controlling environmental contamination.
Further, during the FDA’s walk-through, auditors saw a big pool of water on a warehouse floor where several pallets of completed injectable drugs were kept. There was a black mold-like growth on the floor near an air condenser, as well.
